Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Constipation Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256932
• Other study ID #: SB-767905/012
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2005
• Last updated: September 1, 2015
• Start date: August 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2011
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Has consented to participate in this study.

• Taking opioid therapy for persistent non-cancer pain.

• Has bowel dysfunction mainly due to opioids.

• Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.

• Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).

• Willing to report daily bowel symptoms.

Exclusion criteria:

• Pregnant, lactating, or planning to become pregnant.

• Not ambulatory.

• Participated in another trial with an investigational drug in the past 30 days.

• Taking opioids for the management of drug addiction or cancer-related pain.

• Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.

• Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.

• HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.

Study Design

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Constipation
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Drug:
• alvimopan
0.5 mg
• Placebo

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Chandler	Quebec
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Langley	British Columbia
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Ishoj
Denmark	GSK Investigational Site	Odense C
Estonia	GSK Investigational Site	Tallinn
Finland	GSK Investigational Site	Helsinki
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Fellbach	Baden-Wuerttemberg
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Huettenberg	Hessen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Pinneberg	Schleswig-Holstein
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Viersen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Villingen-Schwenningen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Ireland	GSK Investigational Site	Cork
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Wroclaw
United Kingdom	GSK Investigational Site	Ashford	Middlesex
United Kingdom	GSK Investigational Site	Bexhill-on-Sea, East Sussex
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Coventry	Warwickshire
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Slough	Berkshire
United Kingdom	GSK Investigational Site	Sunbury-on-Thames	Middlesex
United Kingdom	GSK Investigational Site	Yaxley, Peterborough
United Kingdom	GSK Investigational Site	York
United States	GSK Investigational Site	Alexandria	Virginia
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bala Cynwyd	Pennsylvania
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Beuna Park	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bloomington	Illinois
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Brooksville	Florida
United States	GSK Investigational Site	Brownwood	Texas
United States	GSK Investigational Site	Burbank	California
United States	GSK Investigational Site	Calera	Alabama
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chaska	Minnesota
United States	GSK Investigational Site	Chesapeake	Virginia
United States	GSK Investigational Site	Christiansburg	Virginia
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Colleyville	Texas
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Concord	North Carolina
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Dawsonville	Georgia
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Duarte	California
United States	GSK Investigational Site	East Syracuse	New York
United States	GSK Investigational Site	Edmonds	Washington
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Elkhart	Indiana
United States	GSK Investigational Site	Elkridge	Maryland
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fenton	Missouri
United States	GSK Investigational Site	Fort Meyers	Florida
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Gainsville	Florida
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Haddon Heights	New Jersey
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Hot Springs	Arkansas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Incline Village	Nevada
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jupiter	Florida
United States	GSK Investigational Site	Lacey	Washington
United States	GSK Investigational Site	Lake Jackson	Texas
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Manchester	Missouri
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Maumee	Ohio
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Murrells Inlet	South Carolina
United States	GSK Investigational Site	Muscle Shoals	Alabama
United States	GSK Investigational Site	Nazareth	Pennsylvania
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	Delaware
United States	GSK Investigational Site	Newburgh	Indiana
United States	GSK Investigational Site	Niceville	Florida
United States	GSK Investigational Site	North Miami	Florida
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Oregon City	Oregon
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Ormond Beach	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Picayune	Mississippi
United States	GSK Investigational Site	Portage	Michigan
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Princeton	New Jersey
United States	GSK Investigational Site	Redlands	California
United States	GSK Investigational Site	Rockford	Illinois
United States	GSK Investigational Site	Saginaw	Michigan
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Sun City	Arizona
United States	GSK Investigational Site	Tallassee	Alabama
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Valley Stream	New York
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Warwick	Rhode Island
United States	GSK Investigational Site	Waterbury	Connecticut
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Whitehall	Pennsylvania
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Winter Park	Florida
United States	GSK Investigational Site	Woonsocket	Rhode Island
United States	GSK Investigational Site	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Estonia,  Finland,  Germany,  Ireland,  Poland,  United Kingdom, 

References & Publications (1)

Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare alvimopan with placebo for efficacy in the treatment of OBD
Secondary	Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)