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

January 8, 2014 updated by: AbbVie (prior sponsor, Abbott)

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 3

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Site Reference ID/Investigator# 10044
    • California
      • Burbank, California, United States, 91505
        • Site Reference ID/Investigator# 10070
      • San Diego, California, United States, 92108
        • Site Reference ID/Investigator# 10050
    • Florida
      • Atlantis, Florida, United States, 33462
        • Site Reference ID/Investigator# 10060
      • Hollywood, Florida, United States, 33023
        • Site Reference ID/Investigator# 10069
      • Kissimmee, Florida, United States, 347411
        • Site Reference ID/Investigator# 10045
      • Tampa, Florida, United States, 33603
        • Site Reference ID/Investigator# 10061
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Site Reference ID/Investigator# 10054
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator# 10071
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Site Reference ID/Investigator# 13604
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Site Reference ID/Investigator# 10053
      • Newburgh, Indiana, United States, 47630
        • Site Reference ID/Investigator# 10055
      • Valparaiso, Indiana, United States, 46383
        • Site Reference ID/Investigator# 10043
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Site Reference ID/Investigator# 10072
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Site Reference ID/Investigator# 10041
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Site Reference ID/Investigator# 10049
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • Site Reference ID/Investigator# 10062
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Site Reference ID/Investigator# 10066
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 10073
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Site Reference ID/Investigator# 10056
    • New York
      • Williamsville, New York, United States, 14221
        • Site Reference ID/Investigator# 10075
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Site Reference ID/Investigator# 10065
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Site Reference ID/Investigator# 10067
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site Reference ID/Investigator# 10047
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Site Reference ID/Investigator# 10052
      • Bridgeville, Pennsylvania, United States, 15017
        • Site Reference ID/Investigator# 10042
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Site Reference ID/Investigator# 10063
    • Texas
      • Austin, Texas, United States, 78705
        • Site Reference ID/Investigator# 10046
      • Austin, Texas, United States, 78756
        • Site Reference ID/Investigator# 10058
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 10059
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Site Reference ID/Investigator# 10048

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

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open-label ABT-712
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
Drug: ABT-712
ABT-712 extended-release tablet
Other Names:
  • Hydrocodone bitartrate and acetaminophen extended-release
  • Hydrocodone and acetaminophen extended-release
EXPERIMENTAL: Double-blind ABT-712
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
Drug: ABT-712
ABT-712 extended-release tablet
Other Names:
  • Hydrocodone bitartrate and acetaminophen extended-release
  • Hydrocodone and acetaminophen extended-release
PLACEBO_COMPARATOR: Double-blind Placebo
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
Drug: Placebo
Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Double-blind baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Double-blind baseline to 4 weeks

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

September 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (ESTIMATE)

September 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-277

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.

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