Conditions: Chronic Low Back Pain
Keywords: Effect on sleep interference by pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 308
Healthy volunteers: no

Brief summary:
The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

Detailed description:
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Arms:
arm 1: 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). arm 2: 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). arm 3: 2 placebo tablets, twice daily, for 4 weeks (double-blind period).

Interventions: intervention 1: ABT-712 intervention 2: Placebo
Intervention descriptions: intervention 1: ABT-712 extended-release tablet intervention 2: Placebo tablet

Protocol document: