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

NCT ID: NCT00803283

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2008-12-31

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.

Conditions

Cancer Pain

Keywords

Pain; Hydromorphone hydrochloride OROS; Morphine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydromprphone Hydrochloride (HCl) OROS

Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Group Type: EXPERIMENTAL

Hydromprphone Hydrochloride (HCl) OROS

Intervention Type: DRUG

Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Morphine Sustain Release (SR)

Participants will receive morphine SR 8 mg every 24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Group Type: ACTIVE_COMPARATOR

Morphine Sustain Release (SR)

Intervention Type: DRUG

Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Interventions

Hydromprphone Hydrochloride (HCl) OROS

Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Intervention Type: DRUG

Morphine Sustain Release (SR)

Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Taiwan Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Taiwan, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Taiwan Ltd

Other Identifiers

42801PAI3008

Identifier Type: -

Identifier Source: secondary_id

CR015328

Identifier Type: -

Identifier Source: org_study_id