Clinical trial NCT00803283: A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain
Official title: A Randomized, Open-Labeled, Multi-Center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Comparing With Morphine SR in Cancer Pain Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer Pain
Keywords: Pain
Hydromorphone hydrochloride OROS
Morphine
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.

Detailed description: This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 \[Day 1\], Visit 2 \[Day 1-13 telephonic\], Visit 3 \[Day 14\], Visit 4 \[Day 15 to Day 21 telephonic\], Visit 5 \[Day 22\], Visit 6 \[Day 23 to 27 telephonic\] and Visit 7 \[Day 28\]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the "worst pain" item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.

Eligibility criteria: Inclusion Criteria:

* Participants with cancer pain and experiencing inadequate pain control on or approaching Step 2 of the World Health Organisation (WHO) analgesic ladder
* Participants with pain scores greater than and equal to 4 on the average in the last 24 hours
* Participants requiring or are expected to require not more than 540 milligram of oral morphine or morphine equivalent every 24 hours for the management of chronic cancer pain
* Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
* Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial

Exclusion Criteria:

* Participants with pure or predominantly neuropathic pain or pain of unknown origin (where a mechanism or physical cause cannot be identified)
* Participants with acute pain or who have pain on movement
* Participants who have received a fentanyl patch within the last 5 days
* Participants intolerant or hypersensitive to hydromorphone or other opioids agonists (chemical substance capable of activating a receptor to induce a full or partial response)
* Participants with recent past history (within the previous 5 years) or current history of drug abuse or alcohol abuse

Primary outcomes:
measure: Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14
timeFrame: Day 14
measure: BPI Questionnaire Item 3 "Worst Pain" Score at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score
timeFrame: Baseline, Day 14, Day 22 and Day 28
measure: BPI Questionnaire Item "Pain Intensity" Score
timeFrame: Baseline, Day 14, Day 22 and Day 28
measure: BPI Questionnaire Item "Pain Relief" Score
timeFrame: Baseline, Day 14, Day 22 and Day 28
measure: BPI Questionnaire Item "Pain Interference" Score
timeFrame: Baseline, Day 14, Day 22 and Day 28
measure: Patient's Global Assessment on Effectiveness
timeFrame: Day 14, Day 22 and Day 28
measure: Investigator's Global Assessment on Effectiveness
timeFrame: Day 14, Day 22 and Day 28
measure: Number of Times the Pain Medication Required for Breakthrough Pain
timeFrame: Baseline up to Day 28
measure: Mean Total Daily Dose (TDD) of Study Medication
timeFrame: Baseline up to day 28
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: