Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

This study has been completed.

First Received: December 21, 2006 Last Updated: December 7, 2009 History of Changes

Sponsor:	Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.
Information provided by:	Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00415597

Purpose

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

Condition	Intervention	Phase
Pain	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride

Further study details as provided by Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.:

Primary Outcome Measures:

Subjects With Treatment Emergent Adverse Events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	467
Study Start Date:	December 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ALO-01: Experimental 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

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415597

Sponsors and Collaborators

Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.

Investigators

Study Director:

James B. Jones, MD, PharmD

Alpharma Pharmaceuticals

More Information

No publications provided

Responsible Party:	King Pharmaceuticals Research and Development, Inc. ( Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development )
Study ID Numbers:	ALO-KNT-302
Study First Received:	December 21, 2006
Results First Received:	September 11, 2009
Last Updated:	December 7, 2009
ClinicalTrials.gov Identifier:	NCT00415597 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.:

chronic pain
joint pain
back pain
diabetic peripheral neuropathy

post herpetic neuralgia
ALO-01
Embeda
Chronic Non-Malignant Pain

Additional relevant MeSH terms:

Morphine
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Sensory System Agents

Therapeutic Uses
Naltrexone
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010