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Hydromorphone

Analgesics, Opioid

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Once-Daily OROS (Osmotic release oral system \[a controlled release oral drug delivery system in the form of a tablet\]) hydromorphone

Type= exact number, unit= mg, number= 4, form= tablet, route= oral, administered from 1st evaluation day (Day 1) to 2nd evaluation day (Day 15±2). Dosage adjustment: If NRS (Numeric Rating Scale) =4 or more then dose can be increased by 4mg until the average pain intensity for the past 24 hours is adjusted to lower than NRS 3. For the treatment of breakthrough pain, if necessary the one-time administration dose of quick-effect OROS Hydromorphone shall be 2mg up to the daily dosage of the study medicine, 12mg.

OROS hydromorphone

Janssen Korea, Ltd Clinical Trial

The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily OROS ("Osmotic Release Oral System" \[a controlled release oral medication delivery system in the form of a tablet\]) hydromorphone for cancer pain treatment in Korean cancer patients.

This is a prospective (expected to happen), open-label (type of clinical study in which both the researchers and participants know which treatment is being administered), multicenter (conducted at multiple centers), single-arm (only one group), study to evaluate the effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if a patient has continuous cancer pain and the investigator deems it necessary to administer the same medicine as the study medication then the patient may participate voluntarily in the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid analgesics (painkiller) may be administered at the same time for the adjustment of cancer pain based on the discretion of the investigator.

Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients

A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients.

Average pain intensity is calculated (on 1st and 2nd evaluation days) for the past 24 hours of the patient using the NRS (Numeric Rating Scale) (0 = No pain, 10 = Unimaginably acute pain). PID (pain intensity difference) %= \[NRS (1st evaluation day) - NRS (2nd evaluation day)\]/ NRS (1st evaluation day).

A survey (questionnaire) to measures the pain intensity, the effect of pain on the performance of everyday life, effect of medicines for pain treatment and degree of pain reduction.

Quality of life measurement survey with 30 questions that ask about the health status of cancer patients.

Patient checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.

Study investigator checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.

Janssen Korea, Ltd., Korea

Oxycodone

Morphine

OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.

Osmotic Release Oral System (OROS) hydromorphone

Janssen Pharmaceutica Clinical Trial

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain

Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain

The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.

The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.

Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.

The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from "very much worse" to "very much improved" (as compared to Baseline).

Janssen Pharmaceutica

An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.

OROS Hydromorphone

Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.

Osmotic Release Oral System (OROS) Hydromorphone

Age Continuous

Sex: Female, Male

The study was prematurely terminated due to administrative reason.

Medical Affairs Manager

Severity item: Worst pain in last 24 hours

Severity item: Least pain in last 24 hours

Severity item: Average pain

Severity item: Pain right now

Interference item: General activity

Interference item: Mood

Interference item: Walking ability

Interference item: Normal work

Interference item: Relationships with other people

Interference item: Sleep

Interference item: Enjoyment of life

OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 8 Milligram (mg)

OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 12 mg

OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 16 mg

OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 20 mg

OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 24 mg

OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 32 mg

OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 36 mg

Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.

Brief Pain Inventory (BPI) Average Score at Baseline

Interference item: Talking ability

OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.

OROS Hydromorphone 40 mg

ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.

Brief Pain Inventory (BPI) Average Score at Day 28

OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.

OROS Hydromorphone (No Dose Indicated)

Number of Participants Given Rescue Pain Medications

Very much improved: Day 28 (n=15)

Much improved: Day 28 (n=15)

Minimally improved: Day 28 (n=15)

No change: Day 28 (n=15)

Minimally worse: Day 28 (n=15)

Very much worse: Day 28 (n=15)

Not evaluated: Day 28 (n=15)

ITT population included all participants who received at least one dose of study medication at Baseline. "n" signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients	NCT01621100	Cancer Pain	OROS hydromorph...	20 Years -	Janssen Korea, Ltd., Korea
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain	NCT01648699	Pain	Osmotic Release...	18 Years - 70 Years	Janssen Pharmaceutica

Spots Global Cancer Trial Database for oros hydromorphone