A Study of Kadian NT in Subjects With Pain Due to Osteoarthritis of the Hip or Knee - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy of Kadian NT compared with placebo for treating moderate to severe chronic pain over a 12 week period.

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

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Plus Naltrexone Hydrochloride ER) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee

Further study details as provided by Alpharma Inc.:

Primary Outcome Measures:

Evaluate the efficacy of Kadian NT (BID) compared with placebo as measured by mean change in diary Brief Pain Index score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Secondary Outcome Measures:

Evaluate the efficacy of Kadian NT (BID) compared with placebo as measured by in-clinic BPI, daily diary BPI, WOMAC Osteoarthritis Index, MOS Sleep Scale, Beck Depression Inventory, and PGIC
Evaluate the safety and tolerability of Kadian NT compared to placebo using AEs, clinical laboratory data, vital signs, and two measures of opioid withdrawal: SOWS and COWS

Estimated Enrollment:	400
Study Start Date:	December 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The primary objective of this study is to evaluate the efficacy of Kadian NT compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary BPI score of average pain (daily scores af average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is 21 years of age or older
Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
Negative pregnancy test if female of childbearing potential
Subject is in general good health
Subject required treatment of joint pain within the last 90 days
Subject has primary diagnosis of OA of the hip or knee

Exclusion Criteria:

Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
Subject is pregnant or breast-feeding
Subject is receiving systemic chemotherapy
Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
Subject has history of major depressive disorder not controlled with medication
Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
Subject has active gastrointestinal disease, with the exception of GERD
Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or NSAID-dependent inflammatory arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420992

Show 81 Study Locations

Sponsors and Collaborators

Alpharma Inc.

Investigators


Study Director:	James B. Jones, MD, PharmD	Alpharma Pharmceuticals

More Information

Study ID Numbers:	ALO-KNT-301
First Received:	January 10, 2007
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00420992
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alpharma Inc.:

hip

knee

pain

osteoarthritis

OA

Kadian

Alpharma

naltrexone

Opioid

morphine

Study placed in the following topic categories:

Morphine

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Naltrexone

Pain

Rheumatic Diseases

Osteoarthritis, Hip

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Narcotic Antagonists

Central Nervous System Depressants

Narcotics

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Alpharma Inc.
Information provided by:	Alpharma Inc.
ClinicalTrials.gov Identifier:	NCT00420992