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Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

acetaminophen

codeine phosphate

dextropropoxyphene hydrochloride

morphine sulfate

oxycodone hydrochloride

management of therapy complications

quality-of-life assessment

Geoff Hanks, MD

RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It is not yet known whether oxycodone works better and is more cost effective than standard therapy in treating patients with cancer pain.

PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works compared with standard pain therapy in treating patients with cancer pain and if it is more cost effective than standard pain therapy.

OBJECTIVES:

Primary

* Compare overall pain management in patients with cancer-related pain treated with oxycodone hydrochloride vs standard three-step analgesic therapy.
* Compare the health economics of these regimens in these patients.

Secondary

* Explore the factors that inform patients' decisions about commencing opioid analgesia.

OUTLINE: This is an open-label, multicenter, randomized, parallel group, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive an analgesic regimen, according to their level of pain, for up to 18 weeks.

  * Step 1: Patients in mild pain receive oral acetaminophen 4 times daily.
  * Step 2: Patients in mild-to-moderate pain receive oral codeine or oral dextropropoxyphene hydrochloride 4 times daily and oral acetaminophen 4 times daily.
  * Step 3: Patients in moderate-to-severe pain receive oral morphine or oral oxycodone hydrochloride 6 times daily (every 4 hours) with or without a non-opioid analgesic.

Patients may also receive an adjuvant drug (i.e., for side effects or for primary indication other than pain management that is analgesic in selected circumstances).

* Arm II: Patients receive oral oxycodone hydrochloride twice daily for up to 18 weeks. Patients may receive a different opioid analgesic or analgesia or adjuvant medication as in arm I, if needed.

Patients in both arms may also receive additional medication for breakthrough pain.

Patients complete a patient-assessment booklet (PAB) daily which includes a Box-Scale (BS)-11 rating for average pain; questions regarding contact (e.g., telephone or visit) with healthcare professionals on that day; and information regarding the number of times escape medication is used.

Quality of life and levels of cancer pain are assessed using the short form of the Brief Pain Inventory (BPI).

After completion of study treatment, patients are followed at 4 weeks.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

An Open, Randomized, Parallel Group Study in Patients With Cancer Pain, To Compare a Two-Step Analgesic Ladder (Non-Opioid to Oxycodone) With Conventional Management Using A Three-Step Approach

University Hospitals Bristol and Weston NHS Foundation Trust

Other Dietary Supplements

Hydromorphone

Benzocaine

Tannic Acid

OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose.

Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.

Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose.

Hydromorphone HCl

Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.

Oxycodone HCl CR

Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding.

Placebo

Johnson & Johnson Pharmaceutical Research and Development Clinical Trial

The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.

This is a double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug is assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), comparative, parallel-group (a clinical trial comparing the response in two or more groups of participants receiving different treatments) study of OROS hydromorphone HCl compared with oxycodone HCl controlled-release in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain. The study will consist of 3 phases: a screening period (up to 14 days before randomization), a dose titration phase (up to 8 days), and a dose maintenance phase (28 days). The study visits will be scheduled at weekly intervals. Eligible participants will be randomly assigned to receive either hydromorphone HCl once daily or oxycodone HCl twice daily (placebo will be administered when necessary for blinding). During titration phase, dosage of hydromorphone HCl or oxycodone HCl will be adjusted upward or downward to achieve stable pain control. It can be from 2 days to 8 days. Participants who complete dose titration will enter into the dose maintenance phase and will receive study treatment for 28 consecutive days. Morphine hydrochloride will be given as rescue analgesic (drug used to control pain) medication for breakthrough pain during the study. Primarily efficacy will be evaluated by measuring change in the score of Brief Pain Inventory (BPI) questionnaire item 'worst pain' at end of maintenance period. Participants' safety will be monitored throughout the study.

An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine.

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine.

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief.

Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Safety set population included all the paricipants with at least 1 dose of study medication administered during the titration phase and at least one assessment of safety data.

Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.

Hydromorphone Hydrochloride (HCl)

Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.

Oxycodone HCl Controlled Release (CR)

Total

Age, Continuous

Sex: Female, Male

Full analysis set (FAS) population set included all the participants who were randomly assigned either of the 2 treatment groups and with at least 1 dose of medication administered during the titration phase and at least one assessment of efficacy.

Director, Established Products

Baseline

Change at Day 29

Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication.

Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29

The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.

Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29

Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29

The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure.

Breakthrough Pain Medication (Rescue Medication) Doses Taken

Titration Phase

Between Titration & Maintenance Phase

Maintenance Phase

Neoplasms

Mouth and Tooth Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Stomatitis

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Mouth Diseases

Stomatognathic Diseases

Quality of Life

Anticonvulsants

Psychotropic Drugs

Methadone

Gabapentin

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy.

All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.

All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Methadone Hydrochloride

Oxycodone Hydrochloride

Quality-of-Life Assessment

Questionnaire Administration

Anurag Singh

This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.

PRIMARY OBJECTIVES:

I. Collect preliminary data on the safety and efficacy of two analgesic regimens that can be used to design larger studies for comparing such regimens.

SECONDARY OBJECTIVES:

I. Examine effects of the treatment regimens on pain control, oral mucositis, and quality-of-life ratings scores during and after chemoradiation therapy (CRT).

TERTIARY OBJECTIVES:

I. To assess treatment regimen effect on patient nutrition and hydration status during and after CRT (weight loss, vitals, oral \[PO\] tolerance, etc.).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive gabapentin PO thrice daily (TID) for up to 7 weeks during radiotherapy.

ARM II: Patients receive gabapentin PO TID, methadone hydrochloride PO twice daily (BID), and oxycodone hydrochloride PO every 8 hours (Q8H) as needed (PRN) for up to 7 weeks during radiotherapy.

All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

After completion of study, patients are followed up at 30 days, and at 3, 6, 9, and 12 months. Patients requiring prolonged analgesic therapy may be followed up every 6 months for 24 months.

Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

Analysis of Analgesia Regimens During Concurrent Chemoradiation for Head and Neck Cancer: A Pilot Study

Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Will be graded and recorded. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate. The frequency of toxicities will be tabulated by grade by treatment arm.

Each patient requiring rescue medication for breakthrough or refractory pain will be counted as a failure for that specific regimen. At the end of the trial, number of failures will be compared between the two treatment arms using Fisher's exact test. Total amount of opioid intake mean will be compared using a t-test between the two arms. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate

The total score of the OMDQ questionnaire will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

The total score of the EORTC questionnaires will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Roswell Park Cancer Institute

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate

Jinhyong Kang, Dr. Ph.D

The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.

5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.

An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.

A 5-day, Multicentre, Randomized, Open-label, Parallel Group, Active Control Pilot Study to Evaluate the Efficacy and Safety of OxyNorm® (Oxycodone Hydrochloride Injection) in Comparison With Morphine Sulfate Through the IV Continuous Infusion Regimen in Patients With Cancer Pain

For the pain assessment value for efficacy assessment, Subjects perform pain grading through Numeric rating score(NRS) from 1 to 10 for the mean pain intensity over the past 7 days at Screening, and mean pain intensity over the past 24 hours at Baseline (Day 0), Day 1, Day 2, Day 3, Day 4, Day 5.

Verbal measurement can be conducted by subjects without using visual data. '0' indicates 'no pain', and as the number increases, the pain gets more severe, and '10' indicates the worst pain.

The dose of the study drugs intravenously administered was checked and recorded every day. The information on the dose administered from baseline to each assessment time point was collected based on records on the chart, and in the event of dose change/end of treatment, pertinent date and time, and dose were recorded accurately on the chart.

‡ Total administered dose of the study drugs (mg)= IV infusion (mg/hr) \* \[(End date - start date) \* 24 + (end time - start time)\] + bolus injection (mg)

The subjects made an assessment of overall treatment satisfaction regarding pain using the PGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse) after baseline and at the end of the study (Day 5).

The investigators made an assessment using the CGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse).

Mundipharma Korea Ltd

The safety analysis was performed regarding AEs, vital signs, physical examination, clinical laboratory test, and ECG in the Safety set involving all subjects who received the study drug after randomization in this clinical study.

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone IV injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate IV injection

<39 years

40-49 years

50-59 years

60-69 years

Age, Customized

Korea, Republic of

Region of Enrollment

Mrs Suyoun Yang/CR head

Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.

Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration

FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline. So, missing data was excluded from analysis. Oxynorm group 32 subjects and Morphine group 31 subjects were analysed for PGIC.

Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization

FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline.

So, the data was missed.

Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection. The 10mg/1ml or 20mg/2ml was injected through intravenous PCA according to patient's pain intensity

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection. The 5mg/5ml or 30mg/2ml was injected through intravenous PCA according to patient's pain intensity.

Overall Study

Substance Related Disorders

Constipation

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Narcotic Antagonists

Naloxone

OxyCodone Naloxone controlled release tablet

Oxycodone Naloxone PR Tablet taken twice daily

Oxycodone Naloxone

Oxycodone PR Tablets

The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

Eligible patients with documented cancer or non-cancer pain, either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid or currently receiving a WHO step III opioid, and having opioid-related constipation defined by either a KESS score ≥9 or the current use of laxatives (≥3 times per week), will be randomly assigned to receive either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain: cancer or non-cancer.

Any patient having completed the study and wishing to receive OXN PR afterwards may enter an optional open extension phase. During this phase, all patients will receive OXN PR and be managed as per the usual practice in the center until commercial OXN PR is available in France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.

Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients

Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain	NCT00378937	Pain Unspecified Adu...	acetaminophen codeine phospha... dextropropoxyph... morphine sulfat... oxycodone hydro... management of t... quality-of-life...	18 Years -	National Cancer Institute (NCI)
An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain	NCT01205126	Pain	Hydromorphone H... Oxycodone HCl C... Placebo	18 Years - 70 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation	NCT02531906	Head and Neck S... Pain Stomatitis	Gabapentin Methadone Hydro... Oxycodone Hydro... Quality-of-Life... Questionnaire A...	18 Years -	Roswell Park Cancer Institute
Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation	NCT02531906	Head and Neck S... Pain Stomatitis	Gabapentin Methadone Hydro... Oxycodone Hydro... Quality-of-Life... Questionnaire A...	18 Years -	Roswell Park Cancer Institute
An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.	NCT02660229	Cancer Pain	Oxycodone Hydro... Morphine Sulpha...	19 Years -	Mundipharma Korea Ltd
An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.	NCT02660229	Cancer Pain	Oxycodone Hydro... Morphine Sulpha...	19 Years -	Mundipharma Korea Ltd
Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain	NCT00378937	Pain Unspecified Adu...	acetaminophen codeine phospha... dextropropoxyph... morphine sulfat... oxycodone hydro... management of t... quality-of-life...	18 Years -	National Cancer Institute (NCI)
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients	NCT01014559	Constipation Pain	Oxycodone Nalox... Oxycodone PR Ta...	18 Years -	Mundipharma SAS

Spots Global Cancer Trial Database for oxycodone hydrochloride