Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Low Back Pain

Treatments: Drug: ABT-712; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763321

M10-277

Details and patient eligibility

About

The primary purpose of the study is 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).

Full 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.

Enrollment: 287 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male and female subjects who voluntarily sign the informed consent
• Diagnosis of CLBP of 6 months duration

Exclusion criteria

• Incapacitated or bedridden subjects
• Subjects with history of surgical or invasive intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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287 participants in 3 patient groups, including a placebo group

Open-label ABT-712

Experimental group

Description:

2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).

Treatment:

Drug: ABT-712

Double-blind ABT-712

Experimental group

Description:

2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).

Treatment:

Drug: ABT-712

Double-blind Placebo

Placebo Comparator group

Description:

2 placebo tablets, twice daily, for 4 weeks (double-blind period).

Treatment:

Drug: Placebo