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

Primary Purpose

Bowel Dysfunction, Constipation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Alvimopan
Alviompan
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Dysfunction focused on measuring constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced, bowel dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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). 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.

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Alvimopan 0.5 mg once daily

Alvimopan 0.5 mg twice daily

Arm Description

0.5 mg once daily (QD)

0.5 mg twice daily (BID)

Outcomes

Primary Outcome Measures

To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcome Measures

Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)

Full Information

First Posted
November 29, 2005
Last Updated
September 1, 2015
Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00259922
Brief Title
Alvimopan For The 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 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Dysfunction, Constipation
Keywords
constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced, bowel dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Alvimopan 0.5 mg once daily
Arm Type
Experimental
Arm Description
0.5 mg once daily (QD)
Arm Title
Alvimopan 0.5 mg twice daily
Arm Type
Experimental
Arm Description
0.5 mg twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Alvimopan
Other Intervention Name(s)
Entereg
Intervention Description
0.5 mg QD
Intervention Type
Drug
Intervention Name(s)
Alviompan
Other Intervention Name(s)
Entereg
Intervention Description
0.5 mg BID
Primary Outcome Measure Information:
Title
To compare alvimopan with placebo for efficacy in the treatment of OBD
Secondary Outcome Measure Information:
Title
Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
GSK Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
GSK Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
GSK Investigational Site
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
GSK Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85205
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
GSK Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
GSK Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
GSK Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
GSK Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
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United States
Facility Name
GSK Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
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United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
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United States
Facility Name
GSK Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
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United States
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GSK Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
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United States
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GSK Investigational Site
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Sacramento
State/Province
California
ZIP/Postal Code
95816
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United States
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GSK Investigational Site
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San Diego
State/Province
California
ZIP/Postal Code
92108
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United States
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GSK Investigational Site
City
San Rafael
State/Province
California
ZIP/Postal Code
94901
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United States
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GSK Investigational Site
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Santa Ana
State/Province
California
ZIP/Postal Code
92704
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United States
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GSK Investigational Site
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Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
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United States
Facility Name
GSK Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
GSK Investigational Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
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United States
Facility Name
GSK Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33441
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United States
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GSK Investigational Site
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Destin
State/Province
Florida
ZIP/Postal Code
32541
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United States
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GSK Investigational Site
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Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
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United States
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GSK Investigational Site
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Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
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United States
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GSK Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
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United States
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GSK Investigational Site
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
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United States
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GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33138
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United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
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United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
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United States
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GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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United States
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GSK Investigational Site
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Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
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United States
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GSK Investigational Site
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St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
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United States
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GSK Investigational Site
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Tampa
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Florida
ZIP/Postal Code
33614
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United States
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GSK Investigational Site
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West Palm Beach
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Florida
ZIP/Postal Code
33401
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United States
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GSK Investigational Site
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Winterhaven
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Florida
ZIP/Postal Code
33880
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United States
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GSK Investigational Site
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Atlanta
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Georgia
ZIP/Postal Code
30338
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United States
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GSK Investigational Site
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Atlanta
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Georgia
ZIP/Postal Code
30342
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United States
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GSK Investigational Site
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Cumming
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Georgia
ZIP/Postal Code
30040
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United States
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GSK Investigational Site
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Marietta
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Georgia
ZIP/Postal Code
30066
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United States
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GSK Investigational Site
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Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
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United States
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GSK Investigational Site
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Meridian
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Idaho
ZIP/Postal Code
83642
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United States
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GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
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United States
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GSK Investigational Site
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
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United States
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GSK Investigational Site
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
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United States
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GSK Investigational Site
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
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United States
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GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
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United States
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GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
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United States
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GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
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United States
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GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
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United States
Facility Name
GSK Investigational Site
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
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United States
Facility Name
GSK Investigational Site
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
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United States
Facility Name
GSK Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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United States
Facility Name
GSK Investigational Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
GSK Investigational Site
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
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United States
Facility Name
GSK Investigational Site
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
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United States
Facility Name
GSK Investigational Site
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48327
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United States
Facility Name
GSK Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
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United States
Facility Name
GSK Investigational Site
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
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United States
Facility Name
GSK Investigational Site
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
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United States
Facility Name
GSK Investigational Site
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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United States
Facility Name
GSK Investigational Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
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United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
GSK Investigational Site
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
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United States
Facility Name
GSK Investigational Site
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
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United States
Facility Name
GSK Investigational Site
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Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
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United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
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United States
Facility Name
GSK Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
GSK Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
GSK Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
GSK Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45450
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
46432
Country
United States
Facility Name
GSK Investigational Site
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
GSK Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Investigational Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
GSK Investigational Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
GSK Investigational Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
GSK Investigational Site
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
GSK Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
GSK Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
GSK Investigational Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37824-1409
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
GSK Investigational Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
GSK Investigational Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0188
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
GSK Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
GSK Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
GSK Investigational Site
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
GSK Investigational Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
GSK Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
GSK Investigational Site
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
GSK Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
GSK Investigational Site
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
GSK Investigational Site
City
Port Lincoln
State/Province
South Australia
ZIP/Postal Code
5606
Country
Australia
Facility Name
GSK Investigational Site
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
GSK Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
GSK Investigational Site
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
GSK Investigational Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
GSK Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
GSK Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3V9
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
GSK Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
GSK Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4T 4J2
Country
Canada
Facility Name
GSK Investigational Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
GSK Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 4E7
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1Y8
Country
Canada
Facility Name
GSK Investigational Site
City
Bonaventure
State/Province
Quebec
ZIP/Postal Code
G0C 1E0
Country
Canada
Facility Name
GSK Investigational Site
City
Saint Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
GSK Investigational Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
GSK Investigational Site
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
GSK Investigational Site
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
GSK Investigational Site
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 4
ZIP/Postal Code
75181
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1183
Country
Hungary
Facility Name
GSK Investigational Site
City
Csongrád
ZIP/Postal Code
6640
Country
Hungary
Facility Name
GSK Investigational Site
City
Heves
ZIP/Postal Code
3360
Country
Hungary
Facility Name
GSK Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
GSK Investigational Site
City
Hamilton
ZIP/Postal Code
2001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Tauranga
ZIP/Postal Code
3001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0027
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0260
Country
Norway
Facility Name
GSK Investigational Site
City
Paradis
ZIP/Postal Code
5231
Country
Norway
Facility Name
GSK Investigational Site
City
Rådahl
ZIP/Postal Code
5235
Country
Norway
Facility Name
GSK Investigational Site
City
Skien
ZIP/Postal Code
N-3710
Country
Norway
Facility Name
GSK Investigational Site
City
Athlone, Cape Town
ZIP/Postal Code
7760
Country
South Africa
Facility Name
GSK Investigational Site
City
Erasmuskloof, Pretoria
ZIP/Postal Code
0048
Country
South Africa
Facility Name
GSK Investigational Site
City
Fourways, Johannesburg
Country
South Africa
Facility Name
GSK Investigational Site
City
Kempton Park
ZIP/Postal Code
1620
Country
South Africa
Facility Name
GSK Investigational Site
City
Kenilworth, Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
GSK Investigational Site
City
Lynnwood, Pretoria
ZIP/Postal Code
0040
Country
South Africa
Facility Name
GSK Investigational Site
City
Tygervalley
ZIP/Postal Code
7536
Country
South Africa
Facility Name
GSK Investigational Site
City
Westridge, Mitchells Plain
ZIP/Postal Code
7798
Country
South Africa
Facility Name
GSK Investigational Site
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
El Ferrol
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
GSK Investigational Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
GSK Investigational Site
City
Jönköping
ZIP/Postal Code
SE-551 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Karlstad
ZIP/Postal Code
SE-651 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
GSK Investigational Site
City
Bern
ZIP/Postal Code
3011
Country
Switzerland
Facility Name
GSK Investigational Site
City
Nottwil
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21292168
Citation
Irving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.
Results Reference
result

Learn more about this trial

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

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