A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427283
• Other study ID #: ONU3705
• Secondary ID: 2011-005061-20
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2011
• Last updated: February 11, 2015
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria include:

• Male and female subjects = 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;

• The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;

• Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

• Subjects with rheumatoid arthritis or other inflammatory arthritis;

• Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;

• Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;

• Subjects with chronic constipation not related to opioid use;

• Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;

• Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Constipation
• Low Back Pain

Intervention

Drug:
• Oxycodone/Naloxone controlled-release
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
• Oxycodone HCl controlled-release
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
• Placebo
Placebo tablets to match OXN or OXY taken orally every 12 hours

Locations

Country	Name	City	State
United States	Investigational Site	Alabaster	Alabama
United States	Investigational Site	Allen	Texas
United States	Investigational Site	Anaheim	California
United States	Investigational Site	Anaheim	California
United States	Investigational Site	Artesia	California
United States	Investigational Site	Atco	New Jersey
United States	Investigational Site	Atlanta	Georgia
United States	Investigational Site	Austell	Georgia
United States	Investigational Site	Austin	Texas
United States	Investigational Site	Aventura	Florida
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Boise	Idaho
United States	Investigational Site	Boise	Idaho
United States	Investigational Site	Bothell	Washington
United States	Investigational Site	Bradenton	Florida
United States	Investigational Site	Brockton	Massachusetts
United States	Investigational Site	Cerritos	California
United States	Investigational Site	Charleston	South Carolina
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Chiefland	Florida
United States	Investigational Site	Chino	California
United States	Investigational Site	Clermont	Florida
United States	Investigational Site	Colorado Springs	Colorado
United States	Investigational Site	Colorado Springs	Colorado
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Danville	Virginia
United States	Investigational Site	Dayton	Ohio
United States	Investigational Site	Daytona Beach	Florida
United States	Investigational Site	Deland	Florida
United States	Investigational Site	Denver	Colorado
United States	Investigational Site	Durham	North Carolina
United States	Investigational Site	Edgewater	Florida
United States	Investigational Site	Edgewood	Kentucky
United States	Investigational Site	El Cajon	California
United States	Investigational Site	Elkin	North Carolina
United States	Investigational Site	Encino	California
United States	Investigational Site	Eugene	Oregon
United States	Investigational Site	Evansville	Indiana
United States	Investigational Site	Florissant	Missouri
United States	Investigational Site	Foley	Alabama
United States	Investigational Site	Fountain Valley	California
United States	Investigational Site	Fresno	California
United States	Investigational Site	Ft. Lauderdale	Florida
United States	Investigational Site	Ft. Myers	Florida
United States	Investigational Site	Garden Grove	California
United States	Investigational Site	Garden Grove	California
United States	Investigational Site	Golden	Colorado
United States	Investigational Site	Great Neck	New York
United States	Investigational Site	Hialeah	Florida
United States	Investigational Site	Hialeah	Florida
United States	Investigational Site	High Point	North Carolina
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Inverness	Florida
United States	Investigational Site	Jackson	Tennessee
United States	Investigational Site	Jacksonville	Florida
United States	Investigational Site	Jacksonville	Florida
United States	Investigational Site	Jacksonville	Florida
United States	Investigational Site	Jenkintown	Pennsylvania
United States	Investigational Site	Kew Gardens	New York
United States	Investigational Site	Laguna Hills	California
United States	Investigational Site	Lake Charles	Louisiana
United States	Investigational Site	Lakewood	California
United States	Investigational Site	Las Vegas	Nevada
United States	Investigational Site	Levittown	Pennsylvania
United States	Investigational Site	Lincoln	California
United States	Investigational Site	Little Rock	Arkansas
United States	Investigational Site	Lomita	California
United States	Investigational Site	Long Beach	California
United States	Investigational Site	McKinney	Texas
United States	Investigational Site	Mechanicsburg	Pennsylvania
United States	Investigational Site	Mesa	Arizona
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami Beach	Florida
United States	Investigational Site	Michigan City	Indiana
United States	Investigational Site	Midlothian	Virginia
United States	Investigational Site	Mobile	Alabama
United States	Investigational Site	Monroe	Louisiana
United States	Investigational Site	Moraine	Ohio
United States	Investigational Site	Myrtle Beach	South Carolina
United States	Investigational Site	Naples	Florida
United States	Investigational Site	Naples	Florida
United States	Investigational Site	New Orleans	Louisiana
United States	Investigational Site	New Smyrna Beach	Florida
United States	Investigational Site	New York	New York
United States	Investigational Site	North Miami	Florida
United States	Investigational Site	North Richland Hills	Texas
United States	Investigational Site	Oceanside	California
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Oldsmar	Florida
United States	Investigational Site	Orange	California
United States	Investigational Site	Orem	Utah
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Oviedo	Florida
United States	Investigational Site	Paramount	California
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Pikesville	Maryland
United States	Investigational Site	Pittsburgh	Pennsylvania
United States	Investigational Site	Plantation	Florida
United States	Investigational Site	Rapid City	South Dakota
United States	Investigational Site	Red Lion	Pennsylvania
United States	Investigational Site	Richmond	Virginia
United States	Investigational Site	Rochester	New York
United States	Investigational Site	Sacramento	California
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	San Bernardino	California
United States	Investigational Site	San Diego	California
United States	Investigational Site	San Diego	California
United States	Investigational Site	Sherwood	Arkansas
United States	Investigational Site	Snellville	Georgia
United States	Investigational Site	State College	Pennsylvania
United States	Investigational Site	Sun Lakes	Arizona
United States	Investigational Site	Tamarac	Florida
United States	Investigational Site	Tampa	Florida
United States	Investigational Site	Thousand Oaks	California
United States	Investigational Site	Toledo	Ohio
United States	Investigational Site	Tomball	Texas
United States	Investigational Site	Torrance	California
United States	Investigational Site	Tucson	Arizona
United States	Investigational Site	Tucson	Arizona
United States	Investigational Site	Warwick	Rhode Island
United States	Investigational Site	West Palm Beach	Florida
United States	Investigational Site	Wichita	Kansas
United States	Investigational Site	Williamsville	New York
United States	Investigational Site	Winston Salem	North Carolina
United States	Investigational Site	Winston-Salem	North Carolina
United States	Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall complete spontaneous bowel movement (CSBM) responder rates	The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY	Weeks 1 through 12	No
Secondary	CSBM Responder at least 50% of the weeks in the double-blind period		Weeks 1 through 12	No
Secondary	Laxative-free Responder at least 50% of the weeks in the double-blind period		Weeks 1 through 12	No