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PENNSAID Gel in Knee Osteoarthritis
NCT01119898Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2010
- Primary completion
- Feb 2011
- Countries
- 1
- Sponsor
- Mallinckrodt Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- Elfenor
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial in osteoarthritis (OA) comparing PENNSAID Gel with Vehicle (2 arms). Primary endpoints: Pain When Walking On A Flat Surface at 4 weeks, Pain When Going Up Or Down Stairs at 4 weeks and 3 more. Started Aug 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PENNSAID Gel
Diclofenac sodium 2.0% w/w applied twice daily
Vehicle
Placebo carrier applied twice daily
03
Who it enrols
Patients with primary OA of the knee, radiologic evidence of OA, on stable pain therapy, experiencing a moderate flare after washout. Excludes secondary OA, severe systemic disease, recent knee surgery, and specific lab abnormalities.
04
Endpoints
Primary
Pain When Walking On A Flat Surface
Pain When Going Up Or Down Stairs
Pain At Night While In Bed
Pain While Sitting Or Lying Down
Pain While Standing
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