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

Phase 4

Completed

• Conditions: Cancer Pain
• Interventions: Drug: OROS hydromorphone

• Registration Number: NCT01621100
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-18
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Cancer pain and require opioid analgesics
• Average pain intensity measured at the baseline (patient's medical status before any treatment or research is done) for the past 24 hours over Numeric Rating Scale (NRS) is 4
• Never taken continuous-type strong opioid analgesics
• Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control

Exclusion Criteria

• Acute digestion related disease, such as dysphagia (difficulty in swallowing), vomiting, no enterokinesia (movements of intestine), intestinal obstruction, acute intestinal stricture (narrowing of a passageway)
• Expected to undergo radioactive treatment (radiation therapy) between Day 1 and Day 15 of study
• Being administered with monoamine oxidase inhibitor (eg, moclobemide, selegiline, toloxatone, etc) or within 2 weeks of administration thereof

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with 50% or more average Pain Intensity Difference (PID) from 1st evaluation day (Day 1) to the 2nd evaluation day (Days 15±2)	up to 17 days	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).

Secondary Outcome Measures

Name	Time	Method
Korean Brief Pain Inventory (K-BPI) scores	up to 17 days	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.
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores	up to 17 days	Quality of life measurement survey with 30 questions that ask about the health status of cancer patients.
Patient's Global Assessment (PGA) scores	up to 17 days	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.
Investigator's Global Assessment scores	up to 17 days	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.