Study of Kadian NT in Subjects With Chronic Moderate to Severe Nonmalignant Pain - Full Text View

Sponsored by:	Alpharma Inc.
Information provided by:	Alpharma Inc.
ClinicalTrials.gov Identifier:	NCT00415597

Purpose

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

Condition	Intervention	Phase
Pain	Drug: Kadian NT (Morphine Plus Naltrexone Hydrochloride ER) Caps.	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Open-Label, Safety Study of Kadian NT (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 Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

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.

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 Inc.

Investigators

Study Director:

James B. Jones, MD, PharmD

Alpharma Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	ALO-KNT-302
Study First Received:	December 21, 2006
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00415597 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alpharma Inc.:

chronic pain
joint pain
back pain

diabetic peripheral neuropathy
post herpetic neuralgia
Chronic Non-Malignant Pain

Study placed in the following topic categories:

Neuralgia, Postherpetic
Morphine
Neuralgia
Narcotic Antagonists
Central Nervous System Depressants
Pain
Narcotics

Back Pain
Peripheral Nervous System Diseases
Naltrexone
Peripheral Nervous System Agents
Analgesics
Arthralgia
Analgesics, Opioid

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 July 02, 2009