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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: Has 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

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, pharmacokinetics, pharmacogenetics (dependent on results from other data)

Full Information

First Posted
November 21, 2005
Last Updated
September 1, 2015
Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00256932
Brief Title
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
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (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 (1:1:1) to one 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
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
518 (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 Title
alvimopan 0.5 mg twice daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
alvimopan
Other Intervention Name(s)
Entereg
Intervention Description
0.5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
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, pharmacokinetics, 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: Has 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
35243
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
Calera
State/Province
Alabama
ZIP/Postal Code
35040
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
Tallassee
State/Province
Alabama
ZIP/Postal Code
36078
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
85032
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
GSK Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
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
Beuna Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
GSK Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
GSK Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
GSK Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
GSK Investigational Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
GSK Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6204
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
Country
United States
Facility Name
GSK Investigational Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
GSK Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
067708
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
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
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
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 Meyers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
GSK Investigational Site
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32607
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
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
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
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
GSK Investigational Site
City
Niceville
State/Province
Florida
ZIP/Postal Code
32578
Country
United States
Facility Name
GSK Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
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
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
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
GSK Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
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
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
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
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
GSK Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
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
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
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
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
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
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
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
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229-5299
Country
United States
Facility Name
GSK Investigational Site
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
GSK Investigational Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
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
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
Facility Name
GSK Investigational Site
City
Fenton
State/Province
Missouri
ZIP/Postal Code
63026
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
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
Incline Village
State/Province
Nevada
ZIP/Postal Code
89452
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
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
GSK Investigational Site
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
GSK Investigational Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
GSK Investigational Site
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
GSK Investigational Site
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
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
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
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
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
GSK Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
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
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
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
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
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
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
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
GSK Investigational Site
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
GSK Investigational Site
City
Nazareth
State/Province
Pennsylvania
ZIP/Postal Code
18064
Country
United States
Facility Name
GSK Investigational Site
City
Whitehall
State/Province
Pennsylvania
ZIP/Postal Code
18052
Country
United States
Facility Name
GSK Investigational Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
GSK Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
GSK Investigational Site
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
GSK Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
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
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
GSK Investigational Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
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
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
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
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
GSK Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23322
Country
United States
Facility Name
GSK Investigational Site
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
GSK Investigational Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
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
Lacey
State/Province
Washington
ZIP/Postal Code
98516
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
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
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
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
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
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
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
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
Chandler
State/Province
Quebec
ZIP/Postal Code
G0C 1K0
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
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
GSK Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
GSK Investigational Site
City
Ishoj
ZIP/Postal Code
2635
Country
Denmark
Facility Name
GSK Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Fellbach
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70736
Country
Germany
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
GSK Investigational Site
City
Villingen-Schwenningen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
78054
Country
Germany
Facility Name
GSK Investigational Site
City
Weinheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69469
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90402
Country
Germany
Facility Name
GSK Investigational Site
City
Huettenberg
State/Province
Hessen
ZIP/Postal Code
35625
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65195
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51069
Country
Germany
Facility Name
GSK Investigational Site
City
Viersen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41749
Country
Germany
Facility Name
GSK Investigational Site
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58455
Country
Germany
Facility Name
GSK Investigational Site
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09111
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
GSK Investigational Site
City
Pinneberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
25421
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10409
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22149
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22525
Country
Germany
Facility Name
GSK Investigational Site
City
Cork
Country
Ireland
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
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
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY4 3AD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW15 3EA
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
SE5 9RS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Yaxley, Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21292169
Citation
Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):185-93. doi: 10.1016/j.jpain.2010.06.012.
Results Reference
result

Learn more about this trial

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

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