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PG-530742 in mild to moderate knee osteoarthritis
NCT00041756Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2002
- Primary completion
- Feb 2004
- Countries
- 2
- Sponsor
- Procter & Gamble
- Modality
- Small Molecules
- Drugs
- PG-116800
- Conditions
- knee osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial of PG-116800 in knee osteoarthritis (OA) (5 arms), sponsored by Procter & Gamble. Primary endpoints: Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint at 12 months and Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score at 12 months. Started Jul 2002; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo tablet twice daily
25 mg PG-530742
25 mg PG-530742 tablet twice daily
50 mg PG-530742
50 mg PG-530742 tablet twice daily
100 mg PG-530742
100 mg PG-530742 tablet twice daily
200 mg PG-530742
200 mg PG-530742 tablet twice daily
03
Who it enrols
Patients with mild to moderate knee osteoarthritis confirmed by radiography. Excludes secondary OA, other knee pain causes, and prior bone/cartilage acting drugs.
04
Endpoints
Primary
Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint
Change in Western Ontario and McMaster Universities Osteoarthritis Index Total Score
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