At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 547 enrolled
Drug / intervention
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) +1 moredrug
Likely dose
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) 80 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, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee
In Brief
A Phase 3 clinical trial evaluating ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) and Placebo for Osteoarthritis and Chronic Pain. Completed, enrolled 547 participants across 81 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Chronic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedJan 2007
Primary CompletionNov 2007
TodayJul 2026
First PostedJan 11, 2007
Enrollment StartDec 1, 2006
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.5 years ago
Interventions
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)drug
capsules, up to 80 mg bid
Placebodrug
capsules, bid