Clinical trial NCT00241722: Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Dysfunction
Constipation
Keywords: bowel dysfunction
constipation
gastrointestinal
opioids
pain
non-cancer pain
opioid-induced
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2005-10-19
Enrollment: 805
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: Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.


Eligibility criteria: Inclusion criteria:

* 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).

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.
* Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.

Primary outcomes:
measure: To compare alvimopan with placebo for long-term safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Muscle Shoals
country: United States
facility: GSK Investigational Site
state: Alabama
city: Northport
country: United States
facility: GSK Investigational Site
state: Alabama
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Sun City
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tempe
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Buena Park
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facility: GSK Investigational Site
state: California
city: Burbank
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state: California
city: Los Gatos
country: United States
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state: California
city: Orange
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state: California
city: Palm Springs
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state: California
city: Pismo Beach
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city: San Diego
country: United States
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city: San Diego
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city: San Diego
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state: California
city: Torrance
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state: California
city: Vista
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state: California
city: Stratford
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state: Connecticut
city: Trumbull
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state: Connecticut
city: Brandon
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facility: GSK Investigational Site
state: Florida
city: Chiefland
country: United States
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state: Florida
city: Clearwater
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state: Florida
city: Clearwater
country: United States
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city: Deerfield Beach
country: United States
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state: Florida
city: DeLand
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state: Florida
city: Fort Myers
country: United States
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country: United States
facility: GSK Investigational Site
state: Florida
city: Holly Hill
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
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state: Florida
city: Jupiter
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facility: GSK Investigational Site
state: Florida
city: Miami
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facility: GSK Investigational Site
state: Florida
city: Ocala
country: United States
facility: GSK Investigational Site
state: Florida
city: Ocala
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Ormond Beach
country: United States
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state: Florida
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country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
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state: Florida
city: Dawsonville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Suwanee
country: United States
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state: Georgia
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state: Idaho
city: Meridian
country: United States
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state: Idaho
city: Arlington Heights
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state: Illinois
city: Bloomington
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state: Illinois
city: Chicago
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state: Illinois
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state: Illinois
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state: Indiana
city: Indianapolis
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state: Indiana
city: Louisville
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state: Kentucky
city: Louisville
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state: Kentucky
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state: Kentucky
city: Baton Rouge
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state: Louisiana
city: Shreveport
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state: Louisiana
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state: Maryland
city: Rockville
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state: Maryland
city: Boston
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facility: GSK Investigational Site
state: Massachusetts
city: Brockton
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facility: GSK Investigational Site
state: Massachusetts
city: Wellesley Hills
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state: Massachusetts
city: Detroit
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state: Michigan
city: Grand Blanc
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state: Michigan
city: Portage
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state: Michigan
city: Traverse City
country: United States
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state: Michigan
city: Chaska
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state: Minnesota
city: Olive Branch
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state: Mississippi
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state: Montana
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state: Nebraska
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state: Nevada
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state: New Hampshire
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state: New Jersey
city: Elizabeth
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city: Albuquerque
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state: New Mexico
city: Lake Success
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state: New York
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state: North Carolina
city: Charlotte
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facility: GSK Investigational Site
state: North Carolina
city: Concord
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hickory
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: Centerville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Clinton
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Oregon City
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
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state: Oregon
city: Carnegie
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Reading
country: United States
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state: Pennsylvania
city: Woonsocket
country: United States
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state: Rhode Island
city: Chattanooga
country: United States
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state: Tennessee
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Brownwood
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
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country: United States
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country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
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state: Texas
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country: United States
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state: Utah
city: Salt Lake City
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state: Utah
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country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Virginia Beach
country: United States
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state: Virginia
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country: United States
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state: Washington
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country: United States
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country: United States
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state: Washington
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country: United States
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state: Washington
city: Charleston
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Broadmeadow
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Carina Heights
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Port Lincoln
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Carlton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Charlottetown
country: Canada
facility: GSK Investigational Site
state: Prince Edward Island
city: Bonaventure
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Chandler
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Drummondville
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Romuald
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois-Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Ishoj
country: Denmark
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kowloon
country: Hong Kong
facility: GSK Investigational Site
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: Cork
country: Ireland
facility: GSK Investigational Site
city: Roosendaal
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Alcorcon
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: El Ferrol
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Jönköping
country: Sweden
facility: GSK Investigational Site
city: Karlstad
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Reading
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Slough
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Sunbury-on-Thames
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Bexhill-on-Sea, East Sussex
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Yaxley, Peterborough
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: