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

NCT ID: NCT00763321

Last Updated: 2014-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Open-label ABT-712

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

Group Type EXPERIMENTAL

ABT-712

Intervention Type DRUG

ABT-712 extended-release tablet

Double-blind ABT-712

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

Group Type EXPERIMENTAL

ABT-712

Intervention Type DRUG

ABT-712 extended-release tablet

Double-blind Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

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ABT-712

ABT-712 extended-release tablet

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Other Intervention Names

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Hydrocodone and acetaminophen extended-release Hydrocodone bitartrate and acetaminophen extended-release

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Quintana Diez, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 10044

Huntsville, Alabama, United States

Site Status

Site Reference ID/Investigator# 10070

Burbank, California, United States

Site Status

Site Reference ID/Investigator# 10050

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 10060

Atlantis, Florida, United States

Site Status

Site Reference ID/Investigator# 10069

Hollywood, Florida, United States

Site Status

Site Reference ID/Investigator# 10045

Kissimmee, Florida, United States

Site Status

Site Reference ID/Investigator# 10061

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 10054

Atlanta, Georgia, United States

Site Status

Site Reference ID/Investigator# 10071

Marietta, Georgia, United States

Site Status

Site Reference ID/Investigator# 13604

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 10053

Evansville, Indiana, United States

Site Status

Site Reference ID/Investigator# 10055

Newburgh, Indiana, United States

Site Status

Site Reference ID/Investigator# 10043

Valparaiso, Indiana, United States

Site Status

Site Reference ID/Investigator# 10072

Prairie Village, Kansas, United States

Site Status

Site Reference ID/Investigator# 10041

Pasadena, Maryland, United States

Site Status

Site Reference ID/Investigator# 10049

Springfield, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 10062

Biloxi, Mississippi, United States

Site Status

Site Reference ID/Investigator# 10066

Florissant, Missouri, United States

Site Status

Site Reference ID/Investigator# 10073

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 10056

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 10075

Williamsville, New York, United States

Site Status

Site Reference ID/Investigator# 10065

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 10067

Fargo, North Dakota, United States

Site Status

Site Reference ID/Investigator# 10047

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 10052

Altoona, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 10042

Bridgeville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 10063

Greer, South Carolina, United States

Site Status

Site Reference ID/Investigator# 10046

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 10058

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 10059

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 10048

Chesapeake, Virginia, United States

Site Status

Countries

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United States

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M10-277

Identifier Type: -

Identifier Source: org_study_id

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