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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420992
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : October 30, 2009
Last Update Posted : September 20, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Chronic Pain Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00420992

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT00420992     History of Changes
Other Study ID Numbers: ALO-KNT-301
First Posted: January 11, 2007    Key Record Dates
Results First Posted: October 30, 2009
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by Pfizer:

Additional relevant MeSH terms:
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Chronic Pain
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists