At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 905 enrolled
Drug / intervention
Hydrocodone bitartrate q24h film-coated tablets +1 moredrug
Likely dose
Hydrocodone bitartrate q24h film-coated tablets 120 mgfrom 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 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Hydrocodone bitartrate q24h film-coated tablets and Placebo to match hydrocodone bitartrate q24h tablets for Chronic Low Back Pain. Completed, enrolled 905 participants across 102 sites.
Detailed Summary
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionSep 2013
Study CompletionOct 2013
TodayJul 2026
First PostedOct 17, 2011
Enrollment StartOct 1, 2011
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.7 years ago
Interventions
Hydrocodone bitartrate q24h film-coated tabletsdrug
Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
Placebo to match hydrocodone bitartrate q24h tabletsdrug
Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily