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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420992
• Other study ID #: ALO-KNT-301
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2007
• Last updated: September 13, 2013
• Start date: December 2006
• Est. completion date: November 2007

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
United States	LVH Neurosciences and Pain Research	Allentown	Pennsylvania
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Orange County Clinical Trials	Anaheim	California
United States	STAT-CARE / Crest Clinical Trials	Anaheim	California
United States	Walter F. Chase, MD, PA	Austin	Texas
United States	Pennsylvania Research Institute	Bensalem	Pennsylvania
United States	The Birmingham Pain Center	Birmingham	Alabama
United States	River Birch Research Alliance	Blue Ridge	Georgia
United States	Northwest Clinical Trials	Boise	Idaho
United States	Southbay Pharma Research	Buena Park	California
United States	Providence Clinical Res. (C-trials)	Burbank	California
United States	The Arthritis Clinic and Carolina Bone and Joint	Charlotte	North Carolina
United States	Community Research	Cincinnati	Ohio
United States	Community Research	Cincinnati	Ohio
United States	Premier Medical Group	Clarksville	Tennessee
United States	SCRI	Cordova	Tennessee
United States	Best Clinical Research	Decatur	Georgia
United States	Mountain View Clinical Research, Inc	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Med Investigators Inc	Fair Oaks	California
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	Commonwealth Primary Care / Fleetwood Clinical Research	Fleetwood	Pennsylvania
United States	MD Clinical	Hallandale Beach	Florida
United States	Quality of Life Medical Center, LLC	Hawaiian Gardens	California
United States	Lovelace Scientific	Henderson	Nevada
United States	Comprehensive Pain Specialists	Hendersonville	Tennessee
United States	Eastern Research	Hialeah	Florida
United States	NervePro Research	Irvine	California
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Drug Study Institiute	Jupiter	Florida
United States	Team Research of Central Texas	Killeen	Texas
United States	FPA Clinical Research	Kissimmee	Florida
United States	UCSD Pain and Palliative Care	La Jolla	California
United States	USCD Pain and Palliative Care	La Jolla	California
United States	Innovative Research of West Florida	Largo	Florida
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Clinical Trials Management, LLC	Mandeville	Louisiana
United States	Drug Studies America	Marietta	Georgia
United States	Non-Surgical Orthopaedic and Spine Center	Marietta	Georgia
United States	SCRI	Memphis	Tennessee
United States	Pharmaceutical Research Associates Inc	Merritt Island	Florida
United States	Integrity Clinical Research, LLC	Milan	Tennessee
United States	Horizon Research Group	Mobile	Alabama
United States	Elkind Headache Center	Mount Vernon	New York
United States	Lousiana Research Associates Inc.	New Orleans	Louisiana
United States	Welborn Clinic	Newburgh	Indiana
United States	Northeast Medical Research Associates, Inc	No Dartmouth	Massachusetts
United States	COR Clinical Research	Oklahoma City	Oklahoma
United States	Cutting Edge Research	Oklahoma City	Oklahoma
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Ormond Medical Arts - Pharmaceutical Research Center	Ormond Beach	Florida
United States	International Clinical Research Institute, Inc	Overland Park	Kansas
United States	University Clinical Research, Inc	Pembroke Pines	Florida
United States	Arizona Center for Clinical Research	Peoria	Arizona
United States	Research Associates of Central Illinois	Peoria	Illinois
United States	Arizona Research Center, Inc	Phoenix	Arizona
United States	Private Practice	Pico Rivera	California
United States	Coastal Medical Research	Port Orange	Florida
United States	HypotheTest, LLC	Roanoke	Virginia
United States	Synergy Medical Education Alliance	Saginaw	Michigan
United States	North San Antonio Healthcare Associates	San Antonio	Texas
United States	Progressive Clinical Research	San Antonio	Texas
United States	Radiant Research, San Antonio Northeast	San Antonio	Texas
United States	Pain Institute of Santa Monica	Santa Monica	California
United States	Pivotal Clinical Research, LLC	Souderton	Pennsylvania
United States	FutureCare Studies	Springfield	Massachusetts
United States	Medex Healthcare Research Inc	St. Louis	Missouri
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Stedman Clinical Trials	Tampa	Florida
United States	Premiere Pharmaceutical Research, LLC	Tempe	Arizona
United States	Tipton Medical and Diagnostic Center	Tipton	Pennsylvania
United States	Clinical Research Source, Inc	Toledo	Ohio
United States	Internal Research Center	Towson	Maryland
United States	New England Research Associates, LLC	Trumbull	Connecticut
United States	Tulsa Clinical Research	Tulsa	Oklahoma
United States	Boling Clinical Trials	Upland	California
United States	Partners in Primary Care	Voorhees	New Jersey
United States	Gold Coast Research LLC	Weston	Florida
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.	randomization to 12 weeks following randomization	No