Phase 2 Chronic Low Back Pain Study

December 23, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Site Reference ID/Investigator# 54875
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 54876
      • Burbank, California, United States, 91505
        • Site Reference ID/Investigator# 54877
      • Lomita, California, United States, 90717
        • Site Reference ID/Investigator# 54873
    • Florida
      • DeLand, Florida, United States, 32720
        • Site Reference ID/Investigator# 54874
      • Oldsmar, Florida, United States, 34677
        • Site Reference ID/Investigator# 54866
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator# 54879
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Site Reference ID/Investigator# 54865
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Site Reference ID/Investigator# 54782
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Site Reference ID/Investigator# 54862
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472-3930
        • Site Reference ID/Investigator# 54878
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 54880
    • New York
      • Williamsville, New York, United States, 14221
        • Site Reference ID/Investigator# 54881
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Site Reference ID/Investigator# 54872
      • Marion, Ohio, United States, 43302
        • Site Reference ID/Investigator# 54863
    • Texas
      • Killeen, Texas, United States, 76543
        • Site Reference ID/Investigator# 54745
      • San Antonio, Texas, United States, 78209-1744
        • Site Reference ID/Investigator# 54742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 2 tablets twice daily
Drug: hydrocodone/acetaminophen extended release
Other Names:
  • ABT-712
Experimental: Double-blind Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 1 tablet twice daily
Drug: hydrocodone/acetaminophen extended release
Other Names:
  • ABT-712
Placebo Comparator: Double-blind Placebo
Placebo, 1 tablet twice daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Double-blind baseline to Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Double-blind baseline to Day 29
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.
Double-blind baseline to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low Back Pain

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe