Phase 3
N=343
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00631319 ↗Enrolled (actual)
343
Serious AEs
2.2%
Results posted
Aug 2020
Primary outcome: Primary: Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase — 0.6; 0.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OROS hydromorphone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase |
0.6; 0.6 | — |
Summary
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) 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
Data sourced from ClinicalTrials.gov (NCT00631319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.