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Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
This study has been completed.
Study NCT00415597   Information provided by Alpharma Inc.
First Received: December 21, 2006   Last Updated: October 28, 2009   History of Changes

December 21, 2006
October 28, 2009
December 2006
March 2008   (final data collection date for primary outcome measure)
Subjects With Treatment Emergent Adverse Events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
To evaluate the long-term safety of Kadian NT administered for up to 12 months.
Complete list of historical versions of study NCT00415597 on ClinicalTrials.gov Archive Site
  • Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Evaluate the long-term efficacy of Kadian NT during a 12-month period by assessing pain intensity (PI)
  • in the past 24 hours using the Brief Pain Inventory (BPI) Short Form, and the Global Assessment of Study Drug
  • Evaluate opioid withdrawal symptoms in subjects who receive Kadian NT upon completion of 12-months exposure
  • or early termination from the study using the Clinical Opiate Withdrawal Scale (COWS)
  • Evaluate plasma naltrexone, 6-B-naltrexol, and morphine concentrations at Visits 2 through 15 in selected male
  • and female subjects for pharmacokinetic study.
 
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
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

Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Pain
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
467
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00415597
Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development, King Pharmaceuticals Research and Development, Inc.
ALO-KNT-302
Alpharma Inc.
 
Study Director: James B. Jones, MD, PharmD Alpharma Pharmaceuticals
Alpharma Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP