At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 510 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Hydrocodone bitartrate 10mgfrom 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 Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Placebo and Hydrocodone bitartrate for Back Pain Lower Back Chronic. Completed, enrolled 510 participants across 51 sites.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain Lower Back Chronic
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionOct 2011
TodayJul 2026
First PostedMar 5, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.3 years ago
Interventions
Placebodrug
Capsules, no active substance, shells identical to active comparator capsules
Hydrocodone bitartratedrug
dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg