CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 287 enrolled
Drug / intervention
ABT-712 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00763321
NCT00763321Phase 3Completed
CompareCT.gov

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

AbbVie (prior sponsor, Abbott)·interventional·Posted Sep 30, 2008·Updated Feb 6, 2014

In Brief

A Phase 3 clinical trial evaluating ABT-712 and Placebo for Chronic Low Back Pain. Completed, enrolled 287 participants across 31 sites.

Detailed 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 mechanical chronic low back pain (CLBP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2008
Enrollment StartSep 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago

Interventions

ABT-712drug

ABT-712 extended-release tablet

Placebodrug

Placebo tablet