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Long-Term Safety Evaluation Of 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
Alvimopan
Placebo
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 bowel dysfunction, constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced

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). 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alvimopan 0.5 mg Twice Daily (BID)

Placebo

Arm Description

0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.

Placebo was administered orally BID for 12 months.

Outcomes

Primary Outcome Measures

To compare alvimopan with placebo for long-term safety and tolerability

Secondary Outcome Measures

Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)

Full Information

First Posted
October 17, 2005
Last Updated
August 29, 2017
Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00241722
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2005 (Actual)
Primary Completion Date
February 1, 2007 (Actual)
Study Completion Date
February 1, 2007 (Actual)

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) 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alvimopan 0.5 mg Twice Daily (BID)
Arm Type
Experimental
Arm Description
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was administered orally BID for 12 months.
Intervention Type
Drug
Intervention Name(s)
Alvimopan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To compare alvimopan with placebo for long-term safety and tolerability
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
Time Frame
12 months

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). 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.
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
35242
Country
United States
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
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
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
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
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
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
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
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
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United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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United States
Facility Name
GSK Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
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United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
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United States
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
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United States
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
GSK Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
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United States
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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United States
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GSK Investigational Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
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United States
Facility Name
GSK Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
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United States
Facility Name
GSK Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
GSK Investigational Site
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92121
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United States
Facility Name
GSK Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90503
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United States
Facility Name
GSK Investigational Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
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United States
Facility Name
GSK Investigational Site
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
6497
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United States
Facility Name
GSK Investigational Site
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
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United States
Facility Name
GSK Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
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
33756
Country
United States
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
GSK Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33441
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United States
Facility Name
GSK Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
GSK Investigational Site
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
GSK Investigational Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
GSK Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
GSK Investigational Site
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
Facility Name
GSK Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
GSK Investigational Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
GSK Investigational Site
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
GSK Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
GSK Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
GSK Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
GSK Investigational Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
GSK Investigational Site
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
GSK Investigational Site
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
GSK Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
GSK Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
GSK Investigational Site
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
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
Country
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
Country
United States
Facility Name
GSK Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
GSK Investigational Site
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
GSK Investigational Site
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
GSK Investigational Site
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
GSK Investigational Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
GSK Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
GSK Investigational Site
City
Manchester
State/Province
Missouri
ZIP/Postal Code
63021
Country
United States
Facility Name
GSK Investigational Site
City
Nixa
State/Province
Missouri
ZIP/Postal Code
65714
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
GSK Investigational Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
GSK Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89015
Country
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
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
GSK Investigational Site
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
GSK Investigational Site
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
GSK Investigational Site
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
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
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
GSK Investigational Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
GSK Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
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
45219
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
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
Clinton
State/Province
Oklahoma
ZIP/Postal Code
73601
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
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
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
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
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States
Facility Name
GSK Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
GSK Investigational Site
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
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
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
Facility Name
GSK Investigational Site
City
Brownwood
State/Province
Texas
ZIP/Postal Code
76801
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
GSK Investigational Site
City
Grand Prairie
State/Province
Texas
ZIP/Postal Code
75052
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
GSK Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
GSK Investigational Site
City
Lancaster
State/Province
Texas
ZIP/Postal Code
75146
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
78238
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84120
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
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
GSK Investigational Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98226
Country
United States
Facility Name
GSK Investigational Site
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
GSK Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
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
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
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
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
Vienna
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3C 3P1
Country
Canada
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
GSK Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
GSK Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
GSK Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
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
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 5R3
Country
Canada
Facility Name
GSK Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
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
P3E 1H5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
GSK Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
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
Chandler
State/Province
Quebec
ZIP/Postal Code
G0C 1K0
Country
Canada
Facility Name
GSK Investigational Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 1H8
Country
Canada
Facility Name
GSK Investigational Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3M 3A9
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
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
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
Ishoj
ZIP/Postal Code
2635
Country
Denmark
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Kowloon
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Kwun Tong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Pokfulam
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
GSK Investigational Site
City
Cork
Country
Ireland
Facility Name
GSK Investigational Site
City
Roosendaal
ZIP/Postal Code
4708 AE
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
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
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
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
GSK Investigational Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG7 3SQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Slough
State/Province
Berkshire
ZIP/Postal Code
SL2 1HD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
State/Province
Glamorgan
ZIP/Postal Code
CF14 9BB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G3 8YJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G69 7AD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sunbury-on-Thames
State/Province
Middlesex
ZIP/Postal Code
TW16 6RH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV6 4DD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bexhill-on-Sea, East Sussex
ZIP/Postal Code
TN39 4SP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leeds
ZIP/Postal Code
LS14 6UH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Yaxley, Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom

12. IPD Sharing Statement

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Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

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