Conditions: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.

Detailed description:
Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).

Arms:
arm 1: 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). arm 2: 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). arm 3: 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).

Interventions: intervention 1: ABT-712 Extended-release intervention 2: Hydrocodone/Acetaminophen Immediate-release intervention 3: Placebo
Intervention descriptions: intervention 1: ABT-712 extended-release tablet intervention 2: Hydrocodone/acetaminophen immediate-release tablet intervention 3: Placebo tablet

Protocol document: