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Completed

NCT Number: NCT01364922

Phase 2 Chronic Low Back Pain Study

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 54875, Tucson, Arizona, United States

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About this study

This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

Exclusion criteria

Subjects with a history of surgical or invasive intervention

Treatment and study plan

Hydrocodone/Acetaminophen Extended Release

Drug

Other names: ABT-712

Placebo

Drug

Primary outcomes

  1. Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)

    Time frame: Double-blind baseline to Day 29

    The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind 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 an ANCOVA model.

Secondary outcomes

  1. Participant's Global Assessment of Back Pain Status at Final Evaluation

    Time frame: Double-blind baseline to Day 29

    The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).

  2. Participant's Global Assessment of Study Drug at Final Evaluation

    Time frame: Double-blind baseline to Day 29

    The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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