Back to resultsOpioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Primary Purpose
Opioid-induced Bowel Dysfunction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-induced Bowel Dysfunction
Eligibility Criteria
Inclusion Criteria:
A patient can be considered for eligibility to participate if he/she:
- Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
- Is diagnosed with OBD
- Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
- Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study
Exclusion Criteria:
A patient cannot be considered for eligibility to participate if he/she:
- Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
Sites / Locations
- North Alabama Research Center
- Innovative Clinical Trials, Inc.
- Achieve Clinical Research
- Alabama Clinical Therapeutics
- G&L Research, LLC
- Healthscan Research
- River Region Research
- Anasazi Internal Medicine PC
- Aureas Research, Inc
- Certified Clinical Research
- California Clinical Research, Inc.
- Family Medical Center
- South Orange County Surgical Medical Group
- Clinical Trials Research
- Clear Vision Research
- Long Beach VA Medical Center
- Clear Vision Research
- Facey Medical Foundation
- North County Clinical Research
- SDS Clinical Trials, Inc.
- Probe Clinical Research Corporation
- Probe Clinical Research Corporation - Santa Ana
- Westlake Medical Research
- Mountain View Clinical Research
- Meridien Research
- Coastal Orthopedics & Pain Management
- Florida Research & Testing, LLC
- Avail Clinical Research
- S&W Clinical Research
- Palm Springs Research Institute
- Kendall South Medical Center, Inc.
- Gastroenterology Group of Naples
- Physicians Regional Medical Group
- Ocala Rheumatology Research Center
- Paddock Park Clinical Research
- Journey Research, Inc.
- Compass Research
- Andres Patron, DO, PA
- Advent Clinical Research Centers
- Gold Coast Research, LLC
- Orthopedic Research Institite
- IC Research
- Sarasota Memorial Pain Care Center
- Tampa Clinical Research
- Southeastern Regional Research Group
- Better Health Clinical Research
- Clinical Research Atlanta
- Advanced Clinical Research
- Sonora Clinical Research
- Nautical Clinical Research
- Anesthesia/Pain Control Indiana University School of Medicine
- Knight Center for Integrated Health
- Ridge Family Practice
- Lee Research Institute
- Kentucky Medical Research Center
- Bluegrass Internal Medicine
- Horizon Research Group
- Miray Medical Center
- The Research Institute
- Coastal Research
- Ashok Jain, MD
- Shores Medical Associates
- Mid-America Clinical Research LLC
- Montana Medical Research, Inc.
- Independent Clinical Researchers
- AB Clinical Trials
- Clinical Research of South Nevada
- Clinical Research Advantage, Inc.
- Lab2Marche
- Aloha Medical Center
- Edison Medical Group
- Clinical Research Program
- Albuquerque Clinical Trials
- Drug Trials America
- Family Health Medical Services PLLC
- U of Rochester
- Medical Frontiers
- Hightop Medical Research Center
- Community Research
- Community Research
- Rapid Medical Research, Inc.
- Parsons Avenue Medical Center
- Hometown Urgent Care
- Northstar Medical Research, LLC
- Pharmacotherpy Research Associates Inc
- COR Clinical Research, LLC
- Sooner Clinical Research
- Sunstone Medical Research
- Fanno Creek Clinic
- McMillen & Magargle
- Omega Medical Research
- Hartwell Research Group
- Degarmo Institute of Medical Research
- Pain Specialists of Charleston
- Health Concepts
- InvestiClin Research
- SCRI Research Center
- Prevention & Strengthening Solutions, Inc.
- FutureSearch Trials of Neurology & Sleep Lab
- Jaron Winston, MD
- KRK Medical Research
- FutureSearch Trials of Dallas, LP
- Pillar Clinical Research, LLC
- Galenos Research
- Diversified Medical Practice, P.A.
- Clinical Trial Network
- Dependable Clinical Research
- Pioneer Research Solutions, Inc.
- Bobby Huynh
- Sun Research Institute
- Spring Clinical Research
- Pioneer Research Solutions
- Lifetree Clinical Research
- ACR Research Salt Lake City
- Virginia Research Center, LLC
- Pain Clinic-Heilig Hart Ziekenhuis Roeselare
- Huisartsenpraktijk De Regenboog
- Dr Capiau - GP Practice
- St. Anne's University Hospital - centrum pro
- Nemocnice Jablonec nad Nisou, p.o.
- Ambulance bolesti, Krajska nemocnice Liberec
- Klaudianova nemocnice Mlada Boleslav
- Clintrial s.r.o.
- Neurologicka ambulance
- Regional Hospital T. B., a.s.
- Schmerzzentrum Berlin
- Schmerztherapeutische- Ärztezentrum Nordstadt
- Schmerz und Palliativzentrum
- NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
- Hagakliniken
- Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
- S3 Clinical Research Centers
- ElyBridge Surgery
- Randalstown Medical Practice
- Sea Road Surgery
- Sheepcot Medical Centre,
- Fylde Coast Clinical Research Ltd
- Ballygomartin Group Practice
- The Waterfront Medical Centre
- Valleyfield Health Center
- Frome Medical Practice
- Mortimer Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lubiprostone
Placebo
Arm Description
24 mcg capsules twice daily (BID)
0 mcg capsules twice daily (BID)
Outcomes
Primary Outcome Measures
Number of Participants Classified as Treatment Responders Within 12 Weeks
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
Secondary Outcome Measures
Number of SBMs Per Week at Week 8
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
Number of SBMs Per Week at Week 12
Number of SBMs Per Week Overall
Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
Full Information
NCT ID
NCT01298219
First Posted
January 20, 2011
Last Updated
February 3, 2020
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01298219
Brief Title
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Official Title
A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Bowel Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Care provider and outcomes assessor were also blinded for this double-blind trial.
Allocation
Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
24 mcg capsules twice daily (BID)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mcg capsules twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
24 mcg administered orally twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No other names
Intervention Description
Matching placebo, 0 mcg administered orally twice daily (BID)
Primary Outcome Measure Information:
Title
Number of Participants Classified as Treatment Responders Within 12 Weeks
Description
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of SBMs Per Week at Week 8
Time Frame
at Week 8
Title
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
Time Frame
within 48 hours post-dose
Title
Number of SBMs Per Week at Week 12
Time Frame
at Week 12
Title
Number of SBMs Per Week Overall
Description
Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
Time Frame
within 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A patient can be considered for eligibility to participate if he/she:
Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
Is diagnosed with OBD
Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study
Exclusion Criteria:
A patient cannot be considered for eligibility to participate if he/she:
Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama Research Center
City
Athens
State/Province
Alabama
ZIP/Postal Code
35811
Country
United States
Facility Name
Innovative Clinical Trials, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
G&L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Healthscan Research
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36109
Country
United States
Facility Name
River Region Research
City
Tallassee
State/Province
Alabama
ZIP/Postal Code
36078
Country
United States
Facility Name
Anasazi Internal Medicine PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Aureas Research, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Certified Clinical Research
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
California Clinical Research, Inc.
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Family Medical Center
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
South Orange County Surgical Medical Group
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Clear Vision Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Clear Vision Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90023
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
North County Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
SDS Clinical Trials, Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Probe Clinical Research Corporation
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Probe Clinical Research Corporation - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Mountain View Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Coastal Orthopedics & Pain Management
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Florida Research & Testing, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33755
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
S&W Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Palm Springs Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Physicians Regional Medical Group
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Paddock Park Clinical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Journey Research, Inc.
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Andres Patron, DO, PA
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
30026
Country
United States
Facility Name
Advent Clinical Research Centers
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Gold Coast Research, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Orthopedic Research Institite
City
Royal Palm Beach
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Facility Name
IC Research
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Sarasota Memorial Pain Care Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34238
Country
United States
Facility Name
Tampa Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Southeastern Regional Research Group
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Better Health Clinical Research
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Sonora Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Nautical Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Anesthesia/Pain Control Indiana University School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Knight Center for Integrated Health
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Ridge Family Practice
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Lee Research Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Kentucky Medical Research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Bluegrass Internal Medicine
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Horizon Research Group
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Coastal Research
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Ashok Jain, MD
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Shores Medical Associates
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Mid-America Clinical Research LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Montana Medical Research, Inc.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Independent Clinical Researchers
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Lab2Marche
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
Aloha Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89183
Country
United States
Facility Name
Edison Medical Group
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
Clinical Research Program
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Family Health Medical Services PLLC
City
Jamestown
State/Province
New York
ZIP/Postal Code
14701
Country
United States
Facility Name
U of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Medical Frontiers
City
Carlisle
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Parsons Avenue Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Hometown Urgent Care
City
Groveport
State/Province
Ohio
ZIP/Postal Code
43125
Country
United States
Facility Name
Northstar Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Pharmacotherpy Research Associates Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sunstone Medical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Fanno Creek Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
McMillen & Magargle
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Hartwell Research Group
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Degarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pain Specialists of Charleston
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
InvestiClin Research
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
SCRI Research Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Prevention & Strengthening Solutions, Inc.
City
Humboldt
State/Province
Tennessee
ZIP/Postal Code
38343
Country
United States
Facility Name
FutureSearch Trials of Neurology & Sleep Lab
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Jaron Winston, MD
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Galenos Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Diversified Medical Practice, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Dependable Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Bobby Huynh
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Spring Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Pioneer Research Solutions
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
ACR Research Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Virginia Research Center, LLC
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Pain Clinic-Heilig Hart Ziekenhuis Roeselare
City
Roeselare
State/Province
Westlaan 123
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Huisartsenpraktijk De Regenboog
City
Antwerp
ZIP/Postal Code
2100
Country
Belgium
Facility Name
Dr Capiau - GP Practice
City
Wetteren
ZIP/Postal Code
9230
Country
Belgium
Facility Name
St. Anne's University Hospital - centrum pro
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Jablonec nad Nisou, p.o.
City
Jablonec nad Nisou
ZIP/Postal Code
466 60
Country
Czechia
Facility Name
Ambulance bolesti, Krajska nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Klaudianova nemocnice Mlada Boleslav
City
Mlada Boleslav
ZIP/Postal Code
293 50
Country
Czechia
Facility Name
Clintrial s.r.o.
City
Praha 10
ZIP/Postal Code
108 00
Country
Czechia
Facility Name
Neurologicka ambulance
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Regional Hospital T. B., a.s.
City
Zlin
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Schmerzzentrum Berlin
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
Schmerztherapeutische- Ärztezentrum Nordstadt
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Schmerz und Palliativzentrum
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Hagakliniken
City
Gothenburg
ZIP/Postal Code
13 28
Country
Sweden
Facility Name
Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
City
Stockholm
ZIP/Postal Code
4186
Country
Sweden
Facility Name
S3 Clinical Research Centers
City
Vällingby
ZIP/Postal Code
Stockholm 162 68
Country
Sweden
Facility Name
ElyBridge Surgery
City
ELY
State/Province
Cardiff
ZIP/Postal Code
CF5 4AE
Country
United Kingdom
Facility Name
Randalstown Medical Practice
City
Randalstown
State/Province
Co Antrim
ZIP/Postal Code
BT41 3AE
Country
United Kingdom
Facility Name
Sea Road Surgery
City
Bexhill on Sea
State/Province
E.Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Sheepcot Medical Centre,
City
Watford
State/Province
Herts
ZIP/Postal Code
WD25 0EA
Country
United Kingdom
Facility Name
Fylde Coast Clinical Research Ltd
City
Blackpool
State/Province
Lancsashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Ballygomartin Group Practice
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT13 3BW
Country
United Kingdom
Facility Name
The Waterfront Medical Centre
City
Barry
State/Province
Wales
ZIP/Postal Code
CF63 4AR
Country
United Kingdom
Facility Name
Valleyfield Health Center
City
Dunfermline
ZIP/Postal Code
KY12 8SJ
Country
United Kingdom
Facility Name
Frome Medical Practice
City
Frome
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
Mortimer Surgery
City
Reading
ZIP/Postal Code
RG7 3SG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
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