Clinical trial NCT00101998: Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Bowel Dysfunction
Keywords: OBD (Induced Bowel Dysfunction)
cancer pain
pain medication
constipation
bowel
bowel dysfunction
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2005-01-19
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

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