A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee - Full Text View

Sponsor:	Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Information provided by:	Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
ClinicalTrials.gov Identifier:	NCT00420992

Purpose

The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Condition	Intervention	Phase
Osteoarthritis Chronic Pain	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) [ Time Frame: randomization to 12 weeks following randomization ] [ Designated as safety issue: No ]

Enrollment:	547
Study Start Date:	December 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ALO-01 Up to 80 mg twice a day (bid)	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) capsules, up to 80 mg bid Other Name: Embeda
Placebo Comparator: Placebo Twice a day (bid)	Drug: Placebo capsules, bid

Detailed Description:

The primary objective of this study is to evaluate the efficacy of ALO-01 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 Brief Pain Inventory (BPI) score of average pain (daily scores of 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 osteoarthritis (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 gastroesophageal reflux disease (GERD)
Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (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 Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Investigators

Study Director:

James B. Jones, MD, PharmD

Alpharma Pharmceuticals

More Information

No publications provided

Responsible Party:	Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development, King Pharmaceuticals Research and Development
ClinicalTrials.gov Identifier:	NCT00420992 History of Changes
Other Study ID Numbers:	ALO-KNT-301
Study First Received:	January 10, 2007
Results First Received:	September 11, 2009
Last Updated:	December 7, 2009
Health Authority:	United States: Food and Drug Administration

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

hip
knee
pain
osteoarthritis
OA
Kadian

Alpharma
naltrexone
Opioid
morphine
Embeda
ALO-01

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naltrexone
Morphine
Narcotic Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012