Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief Summary
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 mechanica...
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 peri...
Eligibility Criteria
Inclusion
- Adult male and female subjects who voluntarily sign the informed consent
- Diagnosis of CLBP of 6 months duration
Exclusion
- Incapacitated or bedridden subjects
- Subjects with history of surgical or invasive intervention
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00763321
Start Date
September 1 2008
End Date
April 1 2009
Last Update
February 6 2014
Active Locations (31)
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1
Site Reference ID/Investigator# 10044
Huntsville, Alabama, United States, 35801
2
Site Reference ID/Investigator# 10070
Burbank, California, United States, 91505
3
Site Reference ID/Investigator# 10050
San Diego, California, United States, 92108
4
Site Reference ID/Investigator# 10060
Atlantis, Florida, United States, 33462