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
Primary Purpose
Cancer Pain
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hydromprphone Hydrochloride (HCl) OROS
Morphine Sustain Release (SR)
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pain focused on measuring Pain, Hydromorphone hydrochloride OROS, Morphine
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydromprphone Hydrochloride (HCl) OROS
Morphine Sustain Release (SR)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score
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 6 "how much pain you have right now" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
BPI Questionnaire Item "Pain Intensity" Score
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 "Pain Intensity" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
BPI Questionnaire Item "Pain Relief" Score
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 "Pain Relief" will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief).
BPI Questionnaire Item "Pain Interference" Score
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 "Pain Interference" will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference).
Patient's Global Assessment on Effectiveness
Participants will evaluate effectiveness by providing rating on the question "'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase" using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Investigator's Global Assessment on Effectiveness
Investigator will evaluate effectiveness by providing rating on the question "'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase" using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Number of Times the Pain Medication Required for Breakthrough Pain
The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.
Mean Total Daily Dose (TDD) of Study Medication
Mean total daily dose of study medication taken during study will be recorded by participants.
Full Information
NCT ID
NCT00803283
First Posted
December 4, 2008
Last Updated
August 8, 2013
Sponsor
Johnson & Johnson Taiwan Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00803283
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Taiwan Ltd
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Pain, Hydromorphone hydrochloride OROS, Morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydromprphone Hydrochloride (HCl) OROS
Arm Type
Experimental
Arm Description
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.
Arm Title
Morphine Sustain Release (SR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydromprphone Hydrochloride (HCl) OROS
Intervention Description
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
Intervention Name(s)
Morphine Sustain Release (SR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14
Description
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).
Time Frame
Day 14
Title
BPI Questionnaire Item 3 "Worst Pain" Score at Day 28
Description
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).
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score
Description
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 6 "how much pain you have right now" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time Frame
Baseline, Day 14, Day 22 and Day 28
Title
BPI Questionnaire Item "Pain Intensity" Score
Description
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 "Pain Intensity" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time Frame
Baseline, Day 14, Day 22 and Day 28
Title
BPI Questionnaire Item "Pain Relief" Score
Description
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 "Pain Relief" will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief).
Time Frame
Baseline, Day 14, Day 22 and Day 28
Title
BPI Questionnaire Item "Pain Interference" Score
Description
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 "Pain Interference" will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference).
Time Frame
Baseline, Day 14, Day 22 and Day 28
Title
Patient's Global Assessment on Effectiveness
Description
Participants will evaluate effectiveness by providing rating on the question "'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase" using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Time Frame
Day 14, Day 22 and Day 28
Title
Investigator's Global Assessment on Effectiveness
Description
Investigator will evaluate effectiveness by providing rating on the question "'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase" using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Time Frame
Day 14, Day 22 and Day 28
Title
Number of Times the Pain Medication Required for Breakthrough Pain
Description
The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.
Time Frame
Baseline up to Day 28
Title
Mean Total Daily Dose (TDD) of Study Medication
Description
Mean total daily dose of study medication taken during study will be recorded by participants.
Time Frame
Baseline up to day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Taiwan, Ltd. Clinical Trial
Organizational Affiliation
Johnson & Johnson Taiwan Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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