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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


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
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