Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Constipation

Opioid-Related Disorders

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Analgesics

All Drugs and Chemicals

Anticonvulsants

Central Nervous System Depressants

Narcotic Antagonists

Bromides

Analgesics, Opioid

Methylnaltrexone

Narcotics

A single dose of methylnaltrexone will be administered subcutaneously to eligible subjects based on weight at the study entry. Since we will include subjects at all stages of cancer management, administering this study drug is considered experimental. We will use the dose approved by FDA, i.e., 0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg.

Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose

Methylnaltrexone bromide

Steven Ades, MD

The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.

Pain is one of the most common and important symptoms of cancer, often requiring opioid analgesics for control. However constipation is one of the most frequent and debilitating side effects of opioids, occurring in 40%-70% of patients being treated for chronic pain. Although laxatives are commonly used to manage opioid-induced constipation, these agents are not always effective or satisfactory. Methylnaltrexone bromide is a peripherally acting antagonist of the mu-opioid receptor. As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is limited. This allows methylnaltrexone to function as a peripherally-acting antagonist in the gastrointestinal tract without impacting opioid-mediated analgesic effects in the central nervous system. The efficacy and safety of methylnaltrexone in treating opioid-induced constipation in patients with advanced disease receiving palliative care has been demonstrated. However the efficacy of this agent has not been evaluated in more active patients who are earlier in their disease course. The present study will evaluate the efficacy and safety of methylnaltrexone for the relief of severe opioid-induced constipation in this population and will attempt to identify factors predictive of methylnaltrexone response.

Methylnaltrexone for Opioid-induced Constipation in Cancer Patients

Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients

University of Vermont

Associate Professor

Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose

Age, Continuous

Sex: Female, Male

Masanori Mori, MD

Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone

Rescue-free Laxation within 24 hours (n=12)

Laxation within 48 hours (n=12)

Laxation After Administration of Subcutaneous Methylnaltrexone

Mean time to rescue-free laxation ≤4 hours (n=11)

Mean time to rescue-free laxation ≤24 hours (n=11)

Mean time to laxation ≤48 hours (n=11)

Time to Laxation After Administration of Subcutaneous Methylnaltrexone

Average pain (0-4 hours) (n=12)

Average pain (4-24 hours) (n=12)

Average pain (24-48 hours) (n=12)

Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone

0-4 hours (n=12)

4-24 hours (n=12)

24-48 hours (n=11)

Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone

Frequency of ≥ 1 laxation (0-4 hours) (n=12)

Frequency of ≥ 1 laxation (4-24 hours) (n=12)

Frequency of ≥ 1 laxation (24-48 hours) (n=11)

Consistency (slight-very hard) (0-4 hours) (n=12)

Consistency (slight-very hard) (4-24 hours) (n=12)

Consistency (slight-very hard)(24-48 hours) (n=11)

Difficulty (severe-very severe) (0-4 hours) (n=12)

Difficulty (severe-very severe)(4-24 hours) (n=12)

Difficulty (severe-very severe)(24-48hours) (n=11)

Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone

Severity (severe-very severe) (0-4 hours) (n=12)

Severity (severe-very severe) (4-24 hours) (n=12)

Severity (severe-very severe) (24-48 hours) (n=11)

Distress (severe-very severe) (0-4 hours) (n=12)

Distress (severe-very severe) (4-24 hours) (n=12)

Distress (severe-very severe) (24-48 hours) (n=11)

Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone

Satisfied-very satisfied (0-4 hours) (n=12)

Satisfied-very satisfied (4-24 hours) (n=12)

Satisfied-very satisfied (24-48 hours) (n=11)

Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone

Overall Study

Nervous System Diseases

Rare Diseases

Back Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

Psychotropic Drugs

Antidepressive Agents

Analgesics, Non-Narcotic

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care.

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.

In both the intervention and control arms of the study, usual medical care will be defined as any and all medical care provided to patients with chronic non-cancer back or neck pain at an Ontario CHC, including: primary care provider consultation visits, prescription medication (e.g., muscle relaxants, anti-inflammatories, anti-depressants, opioid and non-opioid analgesics), referral for diagnostic testing (e.g., lab work, imaging) or specialist consultation, as well as other co-interventions (e.g., visits with nurses, dieticians, social workers, or physiotherapists) as required. All participants will also receive opioid-reduction encouragement as per each CHC's current practices. Due to socioeconomic disadvantages, most CHC patients will be unlikely to access private health care services, including chiropractic care, elsewhere. Nevertheless, the investigators will collect data on other health care utilization and conduct all analyses using an intention-to-treat principle.

Usual Medical Care

Treatment sessions may include high-velocity, low-amplitude spinal manipulative therapy, as well as any or all of the following: spinal mobilization, soft-tissue massage/trigger point therapy, education and reassurance (e.g., pain management, ergonomic and activities of daily living recommendations), and home advice (e.g., icing, spinal stretching, and core muscle strengthening exercises). Primary care providers will also engage participants in a formal collaborative effort with the chiropractic clinicians to reduce opioid use. Consistent with current clinical practice guidelines, participants will be provided up to a maximum of 12 chiropractic visits during the active care period, although participants may continue with treatment after the 8-week period (e.g., one visit, every 2-4 weeks) to manage further episodes of exacerbation/flare-up. Aside from the experimental intervention, participants in both study groups will follow the same protocol to minimize non-specific effects.

Usual Medical Care + Chiropractic Care

Peter C Emary, DC, PhD

Jason W Busse, DC, PhD

Amy L Brown, DC

The investigators will conduct a pilot cluster randomized controlled trial (RCT) of chiropractic care added to usual medical care, versus usual medical care alone, for adult patients prescribed opioid therapy for chronic non-cancer spinal pain at four community health centers (CHCs) in Ontario, Canada. These centers provide services to communities and vulnerable populations with high unemployment rates, multiple co-morbidities, and high rates of chronic musculoskeletal disorders that are commonly managed with prescription opioids.

The investigators hypothesize that a full-scale (definitive) cluster RCT on the impact of chiropractic care on prescription opioid use for chronic non-cancer spinal pain will be feasible within the Ontario CHC context.

The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Ontario CHCs. The CHCs will be paired on clinical characteristics (e.g., size of patient roster, geographic location), and one center from each pair will be randomized to the intervention and control groups. At each of the four centers, the investigators will recruit adult patients with active opioid prescriptions for chronic non-cancer spinal pain (minimum dose of 50 mg morphine equivalents daily) who are not currently receiving chiropractic care and are interested in reducing their opioid dose. Each center (cluster) will be allocated to provide 8 weeks of usual medical care plus chiropractic care or usual medical care alone to enrolled participants. Random cluster allocation will be performed by an investigator blinded to the intervention group assignment. To further minimize the possibility of selection bias, clusters will be identified and recruited before randomization, and all eligible (and consenting) patients in each cluster will be included. The pilot trial will be coordinated by the Methods Centre within the Department of Surgery at McMaster University.

The primary aims of this study will be to: (1) estimate recruitment rates at the individual centers, (2) explore adherence to the study protocol, (3) investigate completeness of data collection, and (4) assess the ability to follow-up participants. The investigators will incorporate qualitative methods during the pilot trial (i.e., convergent, mixed methods experimental design) to complement the feasibility measures. The investigators will also collect preliminary data on the outcomes planned for a definitive trial: opioid use, pain, disability, bothersomeness, satisfaction, other health care utilization, work status, quality of life, and adverse events at 2, 4, 8, and 12 weeks from allocation.

Cluster-randomized, 2-arm, data analyst-blinded feasibility trial

Due to the nature of the intervention, it will not be possible to blind patients, study personnel, or clinicians to treatment allocation. However, data analysts and investigators responsible for interpreting results will be blinded to treatment allocation until all data have been analyzed and interpreted.

The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study

Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial

Supporting information will be made available from the Central Contact Person/Principal Investigator on reasonable request.

Study personnel will collect data on adverse events (e.g., muscle soreness, joint pain, stiffness, headache, dizziness, nausea, vomiting, constipation, radiating symptoms, paresthesia, or fatigue) at each follow-up visit and record this information in an online data capture system (REDCap Cloud). Participants will be asked: "Did you experience any side effects or problems after your last treatment visit? If yes, please specify: (check all that apply) (Pain or stiffness; Numbness/Pins and needles; Headache; Dizziness; Nausea; Vomiting; Constipation; Tiredness/Fatigue; Other, please specify: __________________)".

Recruitment rate of participants, measured as the number of eligible participants recruited (i.e., consented and enrolled) per week at each center.

Participant retention, measured as the percentage of participants successfully followed for the 12-week study period. The investigators will consider the pilot successful if at least 80% follow-up is achieved at 12 weeks for the primary definitive trial outcomes (i.e., total prescribed opioid usage, and levels of pain intensity and function as measured by the Bournemouth Questionnaire).

Participant compliance with appointment schedules, measured as the percentage of scheduled appointments attended. The investigators will consider 70% attendance to signify feasibility.

Measured as the percentage of items completed on patient-reported outcome questionnaires. The investigators will claim feasibility with 80% or greater completion of the Bournemouth and EuroQol 5 Domain (5 level version) questionnaires.

Study personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the number of chronic non-cancer spinal pain-related opioid prescriptions (i.e., unique opioid fills and subsequent refills) from baseline to 12-week follow-up. Opioid dosage will be measured in milligrams (mg) of morphine equivalents daily (MED). To calculate the MED for each prescribed opioid, the investigators will multiply the quantity x the mg per unit dispensed x drug-specific conversion factors. In addition, the investigators will dichotomize opioid dosage as either high (e.g., ≥ 90 mg) MED or low (e.g., \< 90 mg) MED at baseline and each follow-up interval. The threshold for opioid dose will be dependent on the central tendency of MED in the patient sample. The investigators will also conduct a sensitivity analysis using a threshold of 50 mg MED.

The BQ consists of 7 items (i.e., pain intensity, function in activities of daily living, function in social activities, anxiety, depression levels, fear avoidance behavior, and locus of control/self-efficacy), each scored from 0-10 ("0" = no disability, "10" = complete disability) for a total of 70. To optimize interpretability, the investigators will convert mean effects to risk differences using the anchor-based minimally important difference (MID) of the BQ established for chronic low back pain patients.

Self-rated level of bothersomeness on a 5-point Likert scale from "Not at all bothersome" to "Extremely bothersome".

Self-rated satisfaction with care on a 5-point Likert scale from "Very satisfied" to "Very dissatisfied".

(a) Self-rated health status measured on 5 domains (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-point Likert scale from "No problems" to "Extreme problems"; and (b) Self-rated health status measured on a visual analog scale from 0-100 ("0" = worst health imaginable, "100" = best health imaginable). The investigators will convert mean effects to risk differences using the anchor-based MID of the EQ-5D established for chronic low back pain patients to optimize interpretability.

Participants will be asked: "Have you sought help from any other practitioner, such as your GP \[general practitioner\] or another healthcare professional, for this present episode of your painful complaint? If yes, please specify: (check all that apply) (GP; Nurse practitioner; Nurse; Dietician; Social worker; Community health worker; Physiotherapist; Other, please specify: __________________)."

Participants will be asked: "Since starting treatment at this clinic, have you sought help from any other practitioner, such as your GP or another healthcare professional, for your complaint? If yes, please specify: (check all that apply) (GP; Nurse practitioner; Nurse; Dietician; Social worker; Community health worker; Physiotherapist; Other, please specify: __________________)."

Participants will be asked: (a) "Are you currently employed? If yes, what is your occupation: __________________. If no, are you: (please check only one answer) (Retired; Home-maker; Student; Home on doctor's advice; Unemployed; Other, please specify: __________________)"; (b) "Are you receiving any disability benefits because of your spine pain? (please check only one answer) (Yes; No, but it's possible that I will; No, but it's likely I will; No, and it's very unlikely I will)"; and (c) "Are you currently involved with a lawyer (or ongoing litigation) as a result of your spine pain? (please check only one answer) (Yes; No, but it's possible that I will; No, but it's likely I will; No, and it's very unlikely I will)".

Surgical Methods Centre, McMaster University

Michael G. DeGroote Institute for Pain Research and Care

Ontario Chiropractic Association

Alliance for Healthier Communities

Michael G. DeGroote National Pain Centre

Canadian Chiropractic Research Foundation

McMaster University

Postdoctoral fellow, Michael G. DeGroote Institute for Pain Research and Care

Cancer Pain

Morphine

Hydromorphone

OROS hydromorphone HCL ; Morphine sulfate

Alza Corporation Clinical Trial

The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release \[IR\] and sustained-release \[SR\] formulations) using the "worst pain in the past 24 hours" item of the Brief Pain Inventory (BPI). The secondary objective of this study was to compare hydromorphone and morphine in the following variables: other pain measures, various questionnaires, and safety and tolerability variables.

This was a phase-3, multicenter, multinational, randomized (patients are assigned different treatments based on chance), active-controlled, double-blind, multiple-ascending-dose, parallel-group study in adult patients with cancer pain who receive and/or require strong oral or transdermal opioid analgesics (60-540 mg of oral morphine equivalents daily). This study consisted of 2 phases: an initial immediate release (IR) phase and a subsequent slow release (SR) phase. Eligible patients were randomized 1:1 to receive either OROS hydromorphone HCl or morphine sulfate (immediate release formulation in the immediate release phase, slow release formulation in the slow release phase). In the immediate release phase (2-9 days), patients were started on the appropriate initial dose of immediate release medication every 4 hours (q4h), (6 doses/day) using a 5:1 conversion ratio (morphine equivalents:hydromorphone dosage). If the patient had greater than 3 breakthrough-pain episodes requiring additional pain medication in 24 hours, the study medication dosage was increased, at most once a day. When the patient had achieved dose-stable pain control (2 days with 3 or less than 3 breakthrough-pain episodes per day), the patient was permitted to continue into the slow release phase. The patient was given an equivalent dosage of a slow release formulation of the same drug (OROS® hydromorphone HCL each day or morphine sulfate slow release two times per day), administered using a double-dummy technique. Dosage increases were permitted every 2 days if the patient had more than 3 breakthrough-pain episodes in 24 hours. To complete the slow release phase, patients had to achieve dose-stable pain control for at least 2 days.Safety assessments of physical examination, labs and adverse event reporting were done. OROS hydromorphone HCL slow release 8, 16, 32, and 64mg tablets; Morphine sulfate immediate release10, 20, 50 mg capsules;Morphine sulfate slow release 5, 30, 60, 90, 120, 160, and 200mg capsules;hydromorphone immediate release 2, 4, 8 mg;The immediate release medications orally every 4 hours;The OROS hydromorphone slow release formulation orally every 24 hours and morphine slow release orally twice daily.

A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.

A Randomized, Double-Blind, Controlled Trial of Hydromorphone (Immediate and Sustained- Release) vs Morphine (Immediate and Sustained-release) in Cancer Pain

Alza Corporation, DE, USA

Chronic Pain

OROS Hydromorphone HCI (slow release)

The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid therapy on a daily basis for chronic pain conditions. Patients stabilized on prior opioids were converted to OROS hydromorphone slow release and titrated (slowly increased or decreased) to adequate analgesia (pain relief). They were maintained at that dose for 4-10 days and had blood samples drawn over 24 hours on the last day of study.

This was an open-label, repeated-dose study involving patients who required opioid therapy on a daily basis for chronic pain conditions. In this study, baseline evaluations were performed at Visit 1. Patients were given a diary in which to record daily opioid medication use and daily pain-relief ratings throughout the study. During the time between Visit 1 and Visit 2 patients continued taking their prior oral or transdermal opioid medication for pain. Patients were considered stabilized when during usual activity, the total daily dose of baseline medication remained unchanged, with no more than three opioid breakthrough pain medication doses/day administered, for two consecutive days. Patients returned within 1 week of Visit 1 for Visit 2. During this visit, patient's 24-hour baseline oral opioid dose was converted to hydromorphone at a conversion ratio of approximately 5:1 (oral morphine sulfate to oral hydromorphone HCI mg equivalents). Patients were dispensed OROS hydromorphone HCI slow release tablets and were then increased to acceptable analgesia (pain relief). Eligible stabilized patients requiring a total daily dose of at least 8 mg but no more than 64 mg of OROS hydromorphone HCI slow release (exclusive of breakthrough medication) began the 5-10 day maintenance therapy phase at Visit 3. Morphine sulfate (immediate-release tablets) were provided as breakthrough pain medication. Patients returned to the clinic in the morning following a minimum of 4 days of continuous OROS hydromorphone HCI slow release therapy at a constant daily dose for Visit 4. Upon arrival at the clinic, an initial (trough) blood sample was taken prior to witnessed administration of the usual dosage of OROS hydromorphone HCI slow release. The exact time of the drug administration was documented. Patients were instructed to return the following morning and not to consume food or beverage within 3 hours of their scheduled visit. Patients were instructed not to self administer their OROS hydromorphone HCI slow release the following morning; they were dosed in the clinic. Patients could take immediate release morphine sulfate as needed. Patients returned to the clinic the next morning (visit 5) and remained for a 24-hour period for witnessed dosing and plasma (blood) sampling for pharmacokinetic (metabolism/action) analysis. Dosing and plasma (blood) sampling began 24 hours following the time of dosing at the clinic the previous day. Water (240 mL) was taken with the medication. Immediately prior to each blood draw, patients rated their pain intensity using an 11-point scale and rated their pain intensity from 0 (no pain) to 10 (pain as bad as you can imagine). Blood samples for analysis were drawn at: 0 (prior to dosing), 1,2,4,6,8,10,12,15,18,21 and 24 hours after dosing. Urine output was collected over the 24-hour period from selected patients. Vital signs were taken. At the conclusion of Visit 5 or in the event of early study termination, a Global Evaluation and physical examination were performed. The patient's diary was reviewed with the patient and all unused study medication was collected. Safety assessments included vital signs and physical examination at the start and end of study. OROS Hydromorphone HCL (slow release) 8,16,32,and 64 mg tablets orally. Patients were stabilized on prior opioids then converted to OROS Hydromorphone HCL (slow release) and slowly increased or decreased to adequate analgesia. Then the patients were maintained at that dose for 4 - 10 days. Duration of treatment was up to 31 days.

A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain

A Repeated-Dose Pharmacokinetic Evaluation of Dilaudid SR Tablets (Hydromorphone HCI) in Patients With Chronic Pain

OROS hydromorphone HCI CR

The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with chronic cancer pain or chronic non-malignant pain.

This was a Phase 3, multicenter, open-label, extension study to characterize the safety and tolerability of long-term, repeated dosing of OROS hydromorphone in patients with chronic cancer or chronic non-malignant pain. Patients with chronic cancer or chronic non-malignant pain had completed an OROS hydromorphone short-term study (DO-104, DO-105, DO-119) of approximately 4 weeks duration. During this study, patients continued to receive the dose of OROS hydromorphone that they had been receiving in the short-term study, with dose adjustments as needed to control pain and adverse events. Patients were treated on an outpatient basis. The study was extended from 1 year to up to 2 years in duration. Monthly evaluations of patients treated with OROS hydromorphone for chronic pain were performed to identify adverse events, construct a safety and tolerability profile, and assess efficacy. Dose adjustments were permitted to provide for disease progression, pain control, and adverse events. Quarterly physical examinations were performed to detect significant changes in the underlying condition of patients or changes that may have been associated with long-term opioid therapy. OROS hydromorphone 24 hour controlled release tablets in 8, 16, 32 and 64 mg were ingested orally daily up to 1 year with dose adjustments as needed to control pain and adverse events.

Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)

Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI)

OROS Hydromorphone HCI

The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic cancer pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS hydromorphone HCI (slow release). The safety profile for OROS Hydromorphone HCI (slow release) will also be evaluated.

This randomized (patients assigned to treatment by chance), single-blind (with respect to dose), open-label (patients know what study treatment, not dose, they are receiving) repeated dose study evaluating patients with chronic cancer pain was conducted in tandem (together) with a similar protocol in patients with chronic non-malignant pain. A total of 463 patients were enrolled and evaluated in these studies. Patients receiving chronic opioid therapy were converted to once daily OROS hydromorphone (slow release) using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone (slow release) was escalated after every 2 days of therapy until no more than 3 doses of immediate-release (IR) hydromorphone were required in a 24-hour period. Once a patient could be maintained on a stable dose of OROS hydromorphone (slow release) for 3 consecutive days, the patient entered a 2-week maintenance phase. Patients who completed the study were eligible for participation in an OROS hydromorphone (slow release) long-term extension study, Study DO-109. The hypothesis is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain relief, convenient dosing, and enhanced compliance while possibly decreasing the incidence of side effects associated with peak (high) and trough (low) fluctuations in plasma drug concentrations typically seen with immediate-release dosage formulations. Patients received OROS Hydromorphone HCI (slow release) at Visit 2,3, and 4 (either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI (slow release) doses were titrated after every two days of therapy as necessary until dose stabilization occured, followed by a two week Maintenance Therapy Phase.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients	NCT01004393	Neoplasms Constipation Opioid-Related ...	Methylnaltrexon...	18 Years -	University of Vermont
The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study	NCT06160947	Back Pain	Usual Medical C... Usual Medical C...	18 Years -	McMaster University
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	NCT00410540	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain	NCT00410878	Pain Analgesics, Opi...	OROS Hydromorph...	18 Years - 99 Years	Alza Corporation, DE, USA
Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)	NCT00410748	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain	NCT00411034	Analgesics, Opi... Pain	OROS Hydromorph...	18 Years -	Alza Corporation, DE, USA
Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)	NCT00410748	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	NCT00410540	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	NCT00410540	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients	NCT01004393	Neoplasms Constipation Opioid-Related ...	Methylnaltrexon...	18 Years -	University of Vermont

Spots Global Cancer Trial Database for analgesics, opioid