Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Constipation Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101998
• Other study ID #: 3753-009
• Secondary ID: 767905/008
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2005
• Last updated: August 29, 2017
• Start date: October 1, 2003
• Est. completion date: May 1, 2006

Study information

• Verified date: August 2017
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Other known NCT identifiers

• NCT00903513

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: May 1, 2006
• Est. primary completion date: May 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.

• Participant is taking opioid therapy for persistent cancer pain.

• Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].

• Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.

• Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

Exclusion criteria:

• Participant is pregnant or lactating, or planning to become pregnant.

• Participant is not ambulatory.

• Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.

• Participant is unable to eat, drink, take/hold down oral medications.

• Participant is taking opioids for the management of drug addiction.

• Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.

• Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.

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

• Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.

• Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.

• Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Related Conditions & MeSH terms

• Bowel Dysfunction
• Constipation
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Drug:
• alvimopan

• placebo

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Australia	GSK Investigational Site	Daw Park	South Australia
Australia	GSK Investigational Site	Malvern	Victoria
Australia	GSK Investigational Site	Redcliffe	Queensland
Australia	GSK Investigational Site	South Brisbane	Queensland
Australia	GSK Investigational Site	St Leonards	New South Wales
Canada	GSK Investigational Site	Bonaventure	Quebec
Canada	GSK Investigational Site	Chandler	Quebec
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Levis	Quebec
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	North Bay	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Plzen
Czechia	GSK Investigational Site	Praha 10
Finland	GSK Investigational Site	Helsinki
France	GSK Investigational Site	Bordeaux Cedex
France	GSK Investigational Site	Vandoeuvre-Les-Nancy
France	GSK Investigational Site	Villejuif Cedex
Germany	GSK Investigational Site	Goettingen	Niedersachsen
Germany	GSK Investigational Site	Goslar	Niedersachsen
Hong Kong	GSK Investigational Site	Kwun Tong
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Shatin
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Zalaegerszeg-Pozva
India	GSK Investigational Site	Bangalore
Italy	GSK Investigational Site	Busca (CN)	Piemonte
Italy	GSK Investigational Site	Caserta	Campania
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Forlì	Emilia-Romagna
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Novara	Piemonte
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Rimini	Emilia-Romagna
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Netherlands	GSK Investigational Site	Leeuwarden
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Hastings
New Zealand	GSK Investigational Site	Wellington
Pakistan	GSK Investigational Site	Lahore
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Philippines	GSK Investigational Site	Manila
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Otwock
Poland	GSK Investigational Site	Poznan
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St'Petersburg
South Africa	GSK Investigational Site	Durban	KwaZulu- Natal
South Africa	GSK Investigational Site	Groenkloof, Pretoria
South Africa	GSK Investigational Site	Houghton, Johannesburg
South Africa	GSK Investigational Site	Kenilworth, Cape Town
Spain	GSK Investigational Site	Alcorcon
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cordoba
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Jaén
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Sabadell / Barcelona
Spain	GSK Investigational Site	Serra / Valencia
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Soria
Spain	GSK Investigational Site	Valencia
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Chiang Mai
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Newcastle-upon-Tyne
United Kingdom	GSK Investigational Site	Nottingham
United Kingdom	GSK Investigational Site	Sheffield
United Kingdom	GSK Investigational Site	Surrey
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Bethpage	New York
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Duarte	California
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Flint	Michigan
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Hendersonville	North Carolina
United States	GSK Investigational Site	Hot Springs	Arkansas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Station	New York
United States	GSK Investigational Site	Hutchinson	Kansas
United States	GSK Investigational Site	Inverness	Florida
United States	GSK Investigational Site	Jamaica	New York
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	La Verne	California
United States	GSK Investigational Site	Lecanto	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Gatos	California
United States	GSK Investigational Site	Miami Shores	Florida
United States	GSK Investigational Site	Middletown	Ohio
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Modesto	California
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Palm Harbor	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portsmouth	Virginia
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Reno	Nevada
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis Park	Minnesota
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Titusville	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Washington, D.C.	District of Columbia
United States	GSK Investigational Site	Washington, D.C.	District of Columbia
United States	GSK Investigational Site	Webster	Texas
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czechia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Pakistan,  Peru,  Philippines,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.
Secondary	Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.