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

Tracking Information

First Received Date ^ICMJE

January 10, 2007

Last Updated Date

December 7, 2009

Start Date ^ICMJE

December 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00420992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Osteoarthritis
Chronic Pain

Intervention ^ICMJE

Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
capsules, up to 80 mg bid

Other Name: Embeda
Drug: Placebo
capsules, bid

Study Arms / Comparison Groups

ALO-01: Experimental
Up to 80 mg twice a day (bid)

Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
Placebo: Placebo Comparator
Twice a day (bid)

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

547

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00420992

Responsible Party

Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development, King Pharmaceuticals Research and Development

Study ID Numbers ^ICMJE

ALO-KNT-301

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

James B. Jones, MD, PharmD

Alpharma Pharmceuticals

Information Provided By

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

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP