Conditions: Acute Pain
Keywords: moderate to severe acute pain bunionectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 333
Healthy volunteers: no

Brief summary:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

Detailed description:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Arms:
arm 1: TRV130 1 mg IV Q4H x 48 h arm 2: TRV130 2 mg IV Q4H x 48 h arm 3: TRV130 3 mg IV Q4H x 48 h arm 4: TRV130 4 mg IV Q4H x 48 h arm 5: Morphine 4 mg IV Q4H x 48 h arm 6: Placebo (D5W) IV Q4H x 48 h

Interventions: intervention 1: TRV130 intervention 2: Morphine intervention 3: Placebo
Intervention descriptions: intervention 1: TRV130 1 - 4 mg will be administered every 4 hours intervention 2: Morphine 4 mg will be administered every 4 hours intervention 3: Placebo will be administered every 4 hours

Protocol document: