Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis arthritis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 46
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single dose compared with multiple doses.

Detailed description:
This Phase 2a study was conducted in 2 parts. Part A was a randomized, single-dose, double-blind, placebo- and active-controlled, 3-way crossover phase during which participants were administered study medication in the clinical facility. Part B was a 14-day, randomized, double-blind, placebo-controlled, parallel-group, multiple-dose phase in which participants self-administered study medication at home.

Arms:
arm 1: ADL5859: 200 milligrams (mg), capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 2: Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 3: Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 4: ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study arm 5: Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study

Interventions: intervention 1: ADL5859 intervention 2: Naproxen intervention 3: Placebo intervention 4: ADL5859 intervention 5: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol document: