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Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Primary Purpose

Constipation, Bowel Dysfunction

Status
Completed
Phase
Phase 2
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 Constipation focused on measuring OBD (Induced Bowel Dysfunction), cancer pain, pain medication, constipation, bowel, bowel dysfunction

Eligibility Criteria

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

Inclusion criteria: Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit. Participant is taking opioid therapy for persistent cancer pain. Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)]. Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications. Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits. Exclusion criteria: Participant is pregnant or lactating, or planning to become pregnant. Participant is not ambulatory. Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit. Participant is unable to eat, drink, take/hold down oral medications. Participant is taking opioids for the management of drug addiction. Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study. Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit. Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction. Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study. Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study. Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Alvimopan 0.5 mg Twice Daily (BID)

Alvimopan 1 mg Once Daily (QD)

Alvimopan 1 mg Twice Daily (BID)

Placebo

Arm Description

0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.

0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.

0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Placebo was administered orally BID for 3 weeks.

Outcomes

Primary Outcome Measures

Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.

Secondary Outcome Measures

Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Full Information

First Posted
January 18, 2005
Last Updated
August 29, 2017
Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00101998
Brief Title
Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2003 (Actual)
Primary Completion Date
May 1, 2006 (Actual)
Study Completion Date
May 1, 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
A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Bowel Dysfunction
Keywords
OBD (Induced Bowel Dysfunction), cancer pain, pain medication, constipation, bowel, bowel dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (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 BID for 3 weeks.
Arm Title
Alvimopan 1 mg Once Daily (QD)
Arm Type
Experimental
Arm Description
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Arm Title
Alvimopan 1 mg Twice Daily (BID)
Arm Type
Experimental
Arm Description
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was administered orally BID for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
alvimopan
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.
Secondary Outcome Measure Information:
Title
Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit. Participant is taking opioid therapy for persistent cancer pain. Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)]. Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications. Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits. Exclusion criteria: Participant is pregnant or lactating, or planning to become pregnant. Participant is not ambulatory. Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit. Participant is unable to eat, drink, take/hold down oral medications. Participant is taking opioids for the management of drug addiction. Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study. Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit. Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction. Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study. Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study. Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
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
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
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
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
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
GSK Investigational Site
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
GSK Investigational Site
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32604
Country
United States
Facility Name
GSK Investigational Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
GSK Investigational Site
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
GSK Investigational Site
City
Miami Shores
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
GSK Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
GSK Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
GSK Investigational Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
GSK Investigational Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
GSK Investigational Site
City
Titusville
State/Province
Florida
ZIP/Postal Code
32796
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
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
GSK Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
GSK Investigational Site
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
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
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
GSK Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
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
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
GSK Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
GSK Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
GSK Investigational Site
City
Bethpage
State/Province
New York
ZIP/Postal Code
11714
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Station
State/Province
New York
ZIP/Postal Code
11746
Country
United States
Facility Name
GSK Investigational Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
GSK Investigational Site
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28793
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
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
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
GSK Investigational Site
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58503
Country
United States
Facility Name
GSK Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
GSK Investigational Site
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
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
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
GSK Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
GSK Investigational Site
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-5028
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
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
GSK Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1405CUB
Country
Argentina
Facility Name
GSK Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
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
Redcliffe
State/Province
Queensland
ZIP/Postal Code
4020
Country
Australia
Facility Name
GSK Investigational Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
GSK Investigational Site
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
GSK Investigational Site
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
GSK Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
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
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
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
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
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
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
GSK Investigational Site
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
GSK Investigational Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
GSK Investigational Site
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37073
Country
Germany
Facility Name
GSK Investigational Site
City
Goslar
State/Province
Niedersachsen
ZIP/Postal Code
38642
Country
Germany
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
1097
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
GSK Investigational Site
City
Zalaegerszeg-Pozva
ZIP/Postal Code
8900
Country
Hungary
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
GSK Investigational Site
City
Caserta
State/Province
Campania
ZIP/Postal Code
81100
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Forlì
State/Province
Emilia-Romagna
ZIP/Postal Code
47100
Country
Italy
Facility Name
GSK Investigational Site
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47900
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
GSK Investigational Site
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
GSK Investigational Site
City
Busca (CN)
State/Province
Piemonte
ZIP/Postal Code
12022
Country
Italy
Facility Name
GSK Investigational Site
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
GSK Investigational Site
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95124
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Dunedin
ZIP/Postal Code
9001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Hastings
ZIP/Postal Code
4201
Country
New Zealand
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
Facility Name
GSK Investigational Site
City
Lahore
ZIP/Postal Code
54600
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
GSK Investigational Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1069-166 Lisboa
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1070
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1800
Country
Portugal
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117216
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St'Petersburg
ZIP/Postal Code
195247
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Durban
State/Province
KwaZulu- Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
GSK Investigational Site
City
Groenkloof, Pretoria
Country
South Africa
Facility Name
GSK Investigational Site
City
Houghton, Johannesburg
ZIP/Postal Code
2000
Country
South Africa
Facility Name
GSK Investigational Site
City
Kenilworth, Cape Town
ZIP/Postal Code
7745
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
08023
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
GSK Investigational Site
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Sabadell / Barcelona
Country
Spain
Facility Name
GSK Investigational Site
City
Serra / Valencia
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
GSK Investigational Site
City
Soria
ZIP/Postal Code
42002
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
GSK Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

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