Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
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|ClinicalTrials.gov Identifier: NCT00415597|
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : October 29, 2009
Last Update Posted : September 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||467 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Doses given once or twice daily
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
- Subjects With Treatment Emergent Adverse Events [ Time Frame: up to 12 months ]Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
- Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ]Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
- Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 weeks ]Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415597
|Study Director:||James B. Jones, MD, PharmD||Alpharma Pharmaceuticals|