Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Recruiting in Palo Alto (17 mi)
+30 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AbbVie (prior sponsor, Abbott)
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Eligibility Criteria
Inclusion Criteria
Adult male and female subjects who voluntarily sign the informed consent
Diagnosis of CLBP of 6 months duration
Treatment Details
Interventions
- ABT-712 (Other)
- Placebo (Other)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-label ABT-712Experimental Treatment1 Intervention
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
Group II: Double-blind ABT-712Experimental Treatment1 Intervention
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
Group III: Double-blind PlaceboPlacebo Group1 Intervention
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Site Reference ID/Investigator# 10065Winston-Salem, NC
Site Reference ID/Investigator# 10042Bridgeville, PA
Site Reference ID/Investigator# 10062Biloxi, MS
Site Reference ID/Investigator# 10063Greer, SC
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVie (prior sponsor, Abbott)Lead Sponsor