At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 410 enrolled
Drug / intervention
ALO-02 +1 moredrug
Likely dose
ALO-02 160mgfrom 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, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating ALO-02 and Placebo for Chronic Pain and 2 related conditions. Completed, enrolled 410 participants across 52 sites.
Detailed Summary
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain, Low Back Pain, Analgesia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartJun 2012
Primary CompletionJun 2013
TodayJul 2026
First PostedApr 5, 2012
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.2 years ago
Interventions
ALO-02drug
20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
Placebodrug
oral placebo, divided into symmetric doses and administered twice daily