CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 308 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/NCT00761150
NCT00761150Phase 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 29, 2008·Updated Feb 7, 2014

In Brief

A Phase 3 clinical trial evaluating ABT-712 and Placebo for Chronic Low Back Pain. Completed, enrolled 308 participants across 32 sites.

Detailed Summary

The primary purpose of the study was 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 29, 2008
Enrollment StartSep 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.8 years ago

Interventions

ABT-712drug

ABT-712 extended-release tablet

Placebodrug

Placebo tablet