Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
CompletedPhase 3NCT00415597
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
- Sponsor
- Pfizer
- Start date
- 2006-12
- Primary completion
- 2008-03
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 58
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subject 18-70 years of age * Subject agrees to refrain from taking any opioid medications other than study medication during study period. * History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline Exclusion Criteria: * Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated. * Subject is pregnant or breast-feeding. * Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin). * Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit. * Subject has a Body Mass Index (BMI)\>45kg/m2.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00415597