A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OROS hydromorphone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring OA, Chronic Pain, Osteoarthritis, OA Pain, Osteoarthritis Pain, Pain, Hip Pain, Knee Pain, Joint Pain
Eligibility Criteria
Inclusion Criteria
- Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
- Patients required daily opioid medication to treat their chronic osteoarthritis pain
Exclusion Criteria
- Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
- History drug or alcohol abuse
- Fibromyalgia
- Patients who have major depression or anxiety
- Women who are pregnant or breast feeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OROS Hydromorphone
Placebo
Arm Description
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
Outcomes
Primary Outcome Measures
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631319
Brief Title
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
Official Title
A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
OA, Chronic Pain, Osteoarthritis, OA Pain, Osteoarthritis Pain, Pain, Hip Pain, Knee Pain, Joint Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
343 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OROS Hydromorphone
Arm Type
Experimental
Arm Description
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
Intervention Type
Drug
Intervention Name(s)
OROS hydromorphone
Intervention Description
hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
Description
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Time Frame
Baseline, Week 12
Other Pre-specified Outcome Measures:
Title
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase
Time Frame
Baseline to Week 12
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase
Time Frame
Baseline to Week 12
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase
Time Frame
Baseline to Week 12
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase
Time Frame
Baseline to Week 12
Title
Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase
Time Frame
Baseline to Week 12
Title
Time to Treatment Failure From Baseline
Time Frame
within 12 weeks from Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
Patients required daily opioid medication to treat their chronic osteoarthritis pain
Exclusion Criteria
Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
History drug or alcohol abuse
Fibromyalgia
Patients who have major depression or anxiety
Women who are pregnant or breast feeding
12. IPD Sharing Statement
Learn more about this trial
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
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