Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
NCT00415597
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- 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
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain | |||
Official Title ICMJE | 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 | |||
Brief Summary | Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Pain | |||
Intervention ICMJE | Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
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 Other Name: Embeda | |||
Study Arms ICMJE | Experimental: ALO-01
Doses given once or twice daily Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) | |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 467 | |||
Original Enrollment ICMJE | 400 | |||
Actual Study Completion Date ICMJE | March 2008 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00415597 | |||
Other Study ID Numbers ICMJE | ALO-KNT-302 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |