At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 168 enrolled
Drug / intervention
hydrocodone/acetaminophen extended release +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.
A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain
In Brief
A Phase 2 clinical trial evaluating hydrocodone/acetaminophen extended release and Placebo for Chronic Low Back Pain. Completed, enrolled 168 participants across 17 sites.
Detailed Summary
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionOct 2011
TodayJul 2026
First PostedJun 3, 2011
Enrollment StartJun 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.1 years ago
Interventions
hydrocodone/acetaminophen extended releasedrug
Placebodrug