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

NCT00803283 | Terminated Phase 3 Results

• 2 other identifiers: CR01532842801PAI3008
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Pain

Keywords

Pain; Hydromorphone hydrochloride OROS; Morphine

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14

  The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).

  Day 14

• BPI Questionnaire Item 3 "Worst Pain" Score at Day 28

  The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).

  Day 28

Secondary Outcomes (8)

• BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score

  Baseline, Day 14, Day 22 and Day 28

• BPI Questionnaire Item "Pain Intensity" Score

  Baseline, Day 14, Day 22 and Day 28

• BPI Questionnaire Item "Pain Relief" Score

  Baseline, Day 14, Day 22 and Day 28

• BPI Questionnaire Item "Pain Interference" Score

  Baseline, Day 14, Day 22 and Day 28

• Patient's Global Assessment on Effectiveness

  Day 14, Day 22 and Day 28

Study Arms (2)

Hydromprphone Hydrochloride (HCl) OROS

EXPERIMENTAL

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.

Drug: Hydromprphone Hydrochloride (HCl) OROS

Morphine Sustain Release (SR)

ACTIVE COMPARATOR

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.

Drug: Morphine Sustain Release (SR)

Interventions

Hydromprphone Hydrochloride (HCl) OROS 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.

Hydromprphone Hydrochloride (HCl) OROS

Morphine Sustain Release (SR) 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.

Morphine Sustain Release (SR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Cancer Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study had inadequate number of participants. 'The study was terminated early and the data for efficacy assessments were missing.

Results Point of Contact

• Title: Medical Advisor
• Organization: Janssen Taiwan

886-2-23762158

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 12, 2013
• Results First Posted: August 12, 2013

Record last verified: 2013-08