At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 467 enrolled
Drug / intervention
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)drug
Likely dose
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) 100 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 Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain
In Brief
A Phase 3 clinical trial evaluating ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) for Pain. Completed, enrolled 467 participants across 58 sites.
Detailed Summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionMar 2008
TodayJul 2026
First PostedDec 25, 2006
Enrollment StartDec 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.5 years ago
Interventions
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)drug
capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily