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Opioid-induced Bowel Dysfunction 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
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Induced Bowel Dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  • Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
  • Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
  • If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
  • Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
  • If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
  • Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria:

  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
  • Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
  • Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.

Sites / Locations

  • Tuscaloosa VA Medical Center
  • Carl T Hayden VA Medical Center
  • Redpoint Research
  • HOPE Research Institute, LLC
  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
  • Premiere Pharamaceutical Research, LLC
  • Harmony Clinical Research, Inc.
  • Martin Bowen Hefley Knee
  • Advanced Pain Institute
  • Pain Institute of CA
  • Catalina Research Institute, LLC
  • California Pain Center
  • Shreenath Clinical Service
  • Loma Linda University Physicians Medical Group
  • VA Long Beach Healthcare System
  • Rider Research Group
  • Clinicos, LLC
  • Rocky Mountain Gastroenterology Associates
  • Arapahoe Gastroenterology, PC
  • Metro Clinical Research, LLC
  • Clinical Trial Management of Boca Raton, Inc.
  • Florida Institute of Medical Research
  • Drug Study Institute
  • Gastroenterology Group of Naples
  • Kenneth W. Ponder, MD PA
  • North Miami Research, Inc.
  • Renstar Inc.
  • Peninsula Research, Inc
  • DMI Research, Inc.
  • Sunrise Medical Research, Inc.
  • Accord Clinical Research, LLC
  • Meridien Research
  • Lovelace Scientific Resources, Inc.
  • Clinical Research of West Florida, Inc.
  • Stedman Clinical Trials
  • Advanced Pain Management
  • Global Research Partners & Consultants, Incs.
  • Q Clinical Research
  • Apex Medical Research, AMR, Inc.
  • Claude Mandel Medical Center
  • Advanced Pain Care Clinic
  • MediSphere Medical Research Center
  • Davis Clinic, PC
  • University of Kansas Medical Center
  • University of Louisville
  • Gulf Coast Research, LLC
  • Delta Research Partners, LLC
  • Louisiana Research Center, LLC
  • Rehabilitation Team West, PA
  • Columbia Medical Practice/ RxTrials, Inc.
  • Washington County Hospital Association - The Center for Clinical Research
  • Beth Israel Deaconess Medical Center, Harvard Medical School
  • MedVadis Research Corporation
  • Clinical Research Institute of Michigan, LLC
  • Professional Clinical Research, Inc.
  • PCM Medical Services
  • Women's Health Care Specialists, PC
  • Medical Research Associates
  • Center for Digestive Health
  • MAPS Applied Research Center
  • Mayo Clinic
  • Precise Research, Inc.
  • Medex Healthcare Research
  • Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
  • Creighton University Medical Center
  • Advanced Biomedical Research of America
  • Lovelace Scientific Resources, Inc.
  • Gastroenterology Research Associates
  • Central Jersey Medical Research Center
  • Holy Name Hospital, Institute for Clinical Research
  • Advanced Pain Consultants
  • Medex Healthcare Research, Inc.
  • New York University Pain Management Center
  • Research Across America
  • North American Partners
  • Upstate Clinical Research Associates
  • Randolph Medical Associates
  • Duke University Medical Center
  • Carolina Research
  • Carolina Digestive Health Associates
  • Peters Medical Research, LLC
  • Triangle Medical Research
  • Southern Gastroenterology Associates
  • Valley Medical Primary Care
  • Glenway Family Medicine
  • The Ohio State University Medical Center
  • Urgent Care Specialists
  • RAS Health Ltd.
  • University of Toledo - Health Science Campus
  • Lynn Health Science Institute
  • Paradigm Research Professionals, LLP
  • Memorial Clinical Research
  • Medford Medical Clinic, LLP
  • Lehigh Valley Hospital - Neurosciences and Pain Research
  • Einstein Pain Institute
  • Jeffry A. Lindenbaum DO, PC
  • Baptist Medical Tower Suite 740
  • Integrity Clinical Research, LLC
  • Texas Familicare Clinical Research
  • DCOL Center for Clinical Research
  • Bexar Clinical Trials, LLC
  • Advance Research Institute
  • Highland Clinical Research
  • University of Utah
  • New River Valley Research Institute
  • Hampton Roads Institute for Performance and Sports Medicine (HIPS)
  • McGuire Research Institute
  • Northwest Gastroenterology Associates
  • Daniel R. Coulston
  • Hermitage Medicentre
  • Health Sciences Centre
  • St. Joseph's Healthcare Hamilton
  • Pharmaceutical Integrated Research Company
  • DHC Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lubiprostone

Arm Description

0 mcg capsules twice daily (BID)

24 mcg capsules twice daily (BID)

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8

Secondary Outcome Measures

Change From Baseline in Mean Weekly SBM Frequency
For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.
First Post-dose SBM
The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.
Responder Rate
Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.
Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular
Treatment Effectiveness
Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective

Full Information

First Posted
January 9, 2008
Last Updated
December 6, 2019
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00597428
Brief Title
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Acronym
OPAL
Official Title
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (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 this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mcg capsules twice daily (BID)
Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
24 mcg capsules twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza®
Intervention Description
24 mcg capsules twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No other names
Intervention Description
0 mcg capsules twice daily (BID)
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Weekly SBM Frequency
Description
For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.
Time Frame
Baseline, Week 12, and Weeks 1-12
Title
First Post-dose SBM
Description
The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.
Time Frame
24 and 48 hours post-dose
Title
Responder Rate
Description
Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.
Time Frame
Up to 12 weeks
Title
Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
Description
Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular
Time Frame
Weeks 1-12
Title
Treatment Effectiveness
Description
Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective
Time Frame
Weeks 1-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening. Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period. If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment. Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study. If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening. Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study. Exclusion Criteria: Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening. Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting. Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction. Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected). Gastrointestinal or abdominal surgical procedures within 90 days prior to screening. Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egilius L.H. Spierings, M.D., Ph.D.
Organizational Affiliation
MedVadis Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuscaloosa VA Medical Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Carl T Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Redpoint Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
HOPE Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85222
Country
United States
Facility Name
Premiere Pharamaceutical Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Harmony Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85705
Country
United States
Facility Name
Martin Bowen Hefley Knee
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Pain Institute
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Pain Institute of CA
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
California Pain Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Shreenath Clinical Service
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Loma Linda University Physicians Medical Group
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822-5201
Country
United States
Facility Name
Rider Research Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Arapahoe Gastroenterology, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Metro Clinical Research, LLC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Clinical Trial Management of Boca Raton, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Kenneth W. Ponder, MD PA
City
Niceville
State/Province
Florida
ZIP/Postal Code
32578
Country
United States
Facility Name
North Miami Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Renstar Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Peninsula Research, Inc
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
DMI Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Sunrise Medical Research, Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Advanced Pain Management
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Global Research Partners & Consultants, Incs.
City
Calhoun
State/Province
Georgia
ZIP/Postal Code
30701
Country
United States
Facility Name
Q Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
Apex Medical Research, AMR, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Claude Mandel Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States
Facility Name
Advanced Pain Care Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
MediSphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Davis Clinic, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Gulf Coast Research, LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Delta Research Partners, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Rehabilitation Team West, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Columbia Medical Practice/ RxTrials, Inc.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Washington County Hospital Association - The Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
MedVadis Research Corporation
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Professional Clinical Research, Inc.
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49643
Country
United States
Facility Name
PCM Medical Services
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48917
Country
United States
Facility Name
Women's Health Care Specialists, PC
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Facility Name
Medical Research Associates
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
MAPS Applied Research Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Precise Research, Inc.
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Medex Healthcare Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Gastroenterology Research Associates
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
Central Jersey Medical Research Center
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Holy Name Hospital, Institute for Clinical Research
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Advanced Pain Consultants
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
Facility Name
New York University Pain Management Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
North American Partners
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Randolph Medical Associates
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Peters Medical Research, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Triangle Medical Research
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27295
Country
United States
Facility Name
Southern Gastroenterology Associates
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Valley Medical Primary Care
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Glenway Family Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45238
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1228
Country
United States
Facility Name
Urgent Care Specialists
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
RAS Health Ltd.
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
University of Toledo - Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Paradigm Research Professionals, LLP
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Memorial Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Name
Medford Medical Clinic, LLP
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Lehigh Valley Hospital - Neurosciences and Pain Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Einstein Pain Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19414
Country
United States
Facility Name
Jeffry A. Lindenbaum DO, PC
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Baptist Medical Tower Suite 740
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
Texas Familicare Clinical Research
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Bexar Clinical Trials, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Facility Name
Advance Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2410
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Hampton Roads Institute for Performance and Sports Medicine (HIPS)
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23707
Country
United States
Facility Name
McGuire Research Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Northwest Gastroenterology Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Daniel R. Coulston
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Hermitage Medicentre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Pharmaceutical Integrated Research Company
City
London
State/Province
Ontario
ZIP/Postal Code
N5X4E7
Country
Canada
Facility Name
DHC Research
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 3P8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

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