Conditions: Osteoarthritis Knee Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 147
Healthy volunteers: no

Brief summary:
To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.

Detailed description:

Arms:
arm 1: Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. arm 2: Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment. arm 3: Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.

Interventions: intervention 1: Placebo intervention 2: LY545694 49 mg intervention 3: LY545694 105 mg
Intervention descriptions: intervention 1: LY545694 placebo BID po for 5 weeks intervention 2: LY545694 49 mg BID po for 5 weeks. intervention 3: LY545694 105 mg BID po for 5 weeks.

Protocol document: