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

Overview

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).

Full Title of Study: “A Phase 3, Open-Label Period Followed by a Randomized, Double-blind, Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2009

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.

Interventions

  • Drug: ABT-712
    • ABT-712 extended-release tablet
  • Drug: Placebo
    • Placebo tablet

Arms, Groups and Cohorts

  • Experimental: Open-label ABT-712
    • 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
  • Experimental: Double-blind ABT-712
    • 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
  • Placebo Comparator: Double-blind Placebo
    • 2 placebo tablets, twice daily, for 4 weeks (double-blind period).

Clinical Trial Outcome Measures

Primary Measures

  • Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
    • Time Frame: Double-blind baseline to 4 weeks
    • The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.

Secondary Measures

  • Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
    • Time Frame: Double-blind baseline to 4 weeks
    • The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant’s sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie (prior sponsor, Abbott)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pedro Quintana Diez, MD, Study Director, AbbVie

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