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Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

Primary Purpose

Opioid-Induced Bowel Dysfunction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lubiprostone 24
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:

  • Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
  • Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
  • Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria:

  • Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]
  • Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
  • Has plans to participate in another trial with an investigational drug or device during the course of the extension study

Sites / Locations

  • The Birmingham Pain Center
  • Simon Williamson Clinic, PC
  • Alabama Orthopedic Clinic
  • Clinical Research Advantage, Inc./ Mesa Family Medical Center
  • Redpoint Research
  • HOPE Research Institute
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
  • Clinical Research Advantage, Inc.
  • Premiere Pharamaceutical Research, LLC
  • Genova Clinical Research
  • Verona Clinical Research, Inc.
  • Advanced Clinical Therapeutics, LLC
  • Paradigm Clinical Research, Inc.
  • Quality of Life Medical & Research Center, LLC
  • Wilson and Charani
  • Arkansas Pain Research
  • Teton Research, LLC
  • Advanced Clinical Research Institute
  • Orange County Clinical Trials
  • Advanced Pain Institute
  • Impact Clinical Trials
  • Digestive and Liver Disease Specialists
  • RX Clinical Research, Inc.
  • Loma Linda University
  • Pasadena Rehabilitation Institute
  • Northern California Research Corporation
  • Rider Research Group
  • ShahShreenath Clinical Service
  • Clinicos, LLC
  • Lynn Institute of the Rockies
  • Advanced Diagnostic Pain Treatment Center
  • Meridien Research
  • Century Clinical Research Inc
  • International Medical Research
  • Clinical Physiology Associates/Clinical Study Center
  • Southeastern Integrated Medical, PL dba Florida
  • Century Clinical Research
  • Florida Institute of Medical Research
  • Drug Study Institute
  • Sunrise Medical Research, Inc.
  • Kenneth W. Ponder, MD, PA
  • North Miami Research Inc.
  • DMI Health Care Group, Inc.
  • Accord Clinical Research, LLC
  • Meridien Research
  • Clinical Research of West Florida, Inc.
  • Stedman Clinical Trials
  • Palm Beach Research Center
  • Pinnacle Trials Inc.
  • North Georgia Premier Research
  • Best Clinical Research
  • Drug Studies America
  • Millenium Pain Center
  • University of Illinois at Chicago: Department of Medicine
  • Apex Medical Research, AMR, Inc
  • Redhead Research Inc.
  • MediSphere Medical Research Center, LLC
  • Davis Clinic, PC
  • Intergrated Clinical Trial Services, Inc
  • The Pain Treatment Center of the Bluegrass
  • Louisiana Research Center, LLC
  • The Willis-Knighton Interventional Pain Center
  • Pain and Rehabilitation Medicine
  • Columbia Medical Practice/ RxTrials, Inc.
  • Brigham and Women's Hosptial
  • MedVadis Research Corporation
  • Center for Clinical Studies
  • Apex Medical Research, AMR, Inc.
  • Professional Clinical Research - Interlochen
  • Beyer Research
  • Medical Research Associates
  • Center for Digestive Health
  • MAPS Applied Research Center
  • Medex Healthcare Research Inc.
  • Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
  • Office of Stephen H. Miller, MD
  • Affiliated Clinical Research, Inc.
  • Ladder Family Practice
  • Impact Clinical Trials
  • Gastroenterology Research Associates, LLC
  • Central Jersey Medical Research Center
  • Virtua Lumberton Family Physicians
  • Holy Name Hospital
  • Long Island Gastrointestinal Research Group
  • NYU Pain Management Center
  • Research Across America
  • University of Rochester, Pain Treatment Center
  • Upstate Clinical Research Associates
  • Duke University Medical Center
  • Carolina Research
  • Peters Medical Research, LLC
  • The Center for Clinical Research
  • Glenway Family Medicine
  • The Ohio State University Medical Center
  • Hometown Urgent Care and Research
  • RAS Health Ltd.
  • COR Clinical Research, LLC
  • McBride Clinic
  • Memorial Clinical Research
  • Pain Research of Oregon, LLC
  • Medford Medical Clinic, LLP
  • Affinity Research
  • Lehigh Gastroenterology Associates
  • Albert Einstein Healthcare Network Einstein Pain Institute
  • Jeffry A. Lindenbaum DO, PC
  • Trident Institute of Medical Research, LLC
  • Southeastern Clinical Research
  • Comprehensive Pain Specialists, PLLC
  • Integrity Clinical Research, LLC
  • Texas Familicare Clinical Research
  • DCOL Center for Clinical Research
  • Advanced Research Institute
  • Highland Clinical Research
  • New River Valley Research Institute
  • Digestive and Liver Disease Specialists
  • Hampton Roads Institution for Performance and Sports Medicine
  • McGuire VA Medical Center
  • Northwest Gastroenterology Associates
  • VAMC Milwaukee
  • Health Sciences Centre Pain Clinic
  • AIM Health Group London North
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks

Outcomes

Primary Outcome Measures

Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Mean Weekly Bowel Movements (BMs) Per Month
A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)

Secondary Outcome Measures

Number of Participants Classified as Monthly Responders
A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.
Straining Associated With Spontaneous Bowel Movements by Month
Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.
Stool Consistency of Spontaneous Bowel Movements by Month
Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.
Constipation Severity by Month
Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Abdominal Bloating by Month
Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Abdominal Discomfort by Month
Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Bowel Habit Regularity by Month
Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1.
Treatment Effectiveness by Month
Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4.
Mean Weekly Complete SBMs by Month
Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Mean Weekly Complete BMs by Month
Participants rate each BM as complete if their bowels feel completely empty after the BM

Full Information

First Posted
February 11, 2008
Last Updated
January 10, 2020
Sponsor
Sucampo Pharma Americas, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00620061
Brief Title
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Official Title
A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (Actual)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
Intervention Type
Drug
Intervention Name(s)
Lubiprostone 24
Other Intervention Name(s)
Amitiza
Intervention Description
24 mcg capsules for oral administration
Primary Outcome Measure Information:
Title
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Description
A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Mean Weekly Bowel Movements (BMs) Per Month
Description
A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Outcome Measure Information:
Title
Number of Participants Classified as Monthly Responders
Description
A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.
Time Frame
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Straining Associated With Spontaneous Bowel Movements by Month
Description
Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Stool Consistency of Spontaneous Bowel Movements by Month
Description
Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Constipation Severity by Month
Description
Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Abdominal Bloating by Month
Description
Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Abdominal Discomfort by Month
Description
Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Bowel Habit Regularity by Month
Description
Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Treatment Effectiveness by Month
Description
Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4.
Time Frame
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Mean Weekly Complete SBMs by Month
Description
Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Time Frame
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Title
Mean Weekly Complete BMs by Month
Description
Participants rate each BM as complete if their bowels feel completely empty after the BM
Time Frame
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428 Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study Willing to continue to abstain from use of disallowed medications as defined per protocol Exclusion Criteria: Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)] Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit. Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
The Birmingham Pain Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Simon Williamson Clinic, PC
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Alabama Orthopedic Clinic
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Research Advantage, Inc./ Mesa Family Medical Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85203
Country
United States
Facility Name
Redpoint Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85128
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
Clinical Research Advantage, Inc.
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Premiere Pharamaceutical Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Verona Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Advanced Clinical Therapeutics, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Paradigm Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Wilson and Charani
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Pain Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Teton Research, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Orange County Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Pain Institute
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
RX Clinical Research, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pasadena Rehabilitation Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Northern California Research Corporation
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Rider Research Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
ShahShreenath Clinical Service
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Advanced Diagnostic Pain Treatment Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Century Clinical Research Inc
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
International Medical Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Clinical Physiology Associates/Clinical Study Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Southeastern Integrated Medical, PL dba Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Century Clinical Research
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
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
Sunrise Medical Research, Inc.
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
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
DMI Health Care Group, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
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
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
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Pinnacle Trials Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
North Georgia Premier Research
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
Facility Name
Best Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Millenium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
University of Illinois at Chicago: Department of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Apex Medical Research, AMR, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Redhead Research Inc.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
161614
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
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
Intergrated Clinical Trial Services, Inc
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
The Pain Treatment Center of the Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
The Willis-Knighton Interventional Pain Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Pain and Rehabilitation Medicine
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Columbia Medical Practice/ RxTrials, Inc.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Brigham and Women's Hosptial
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
MedVadis Research Corporation
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Center for Clinical Studies
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Apex Medical Research, AMR, Inc.
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Professional Clinical Research - Interlochen
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49641
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
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
Medex Healthcare Research Inc.
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
Office of Stephen H. Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Affiliated Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Ladder Family Practice
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89206
Country
United States
Facility Name
Gastroenterology Research Associates, LLC
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
Virtua Lumberton Family Physicians
City
Lumberton
State/Province
New Jersey
ZIP/Postal Code
08048
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
NYU 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
University of Rochester, Pain Treatment Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
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
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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
Country
United States
Facility Name
Hometown Urgent Care and Research
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
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
McBride Clinic
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
Pain Research of Oregon, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Medford Medical Clinic, LLP
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Affinity Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Lehigh Gastroenterology Associates
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Albert Einstein Healthcare Network Einstein Pain Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Jeffry A. Lindenbaum DO, PC
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Trident Institute of Medical Research, LLC
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Southeastern Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Comprehensive Pain Specialists, PLLC
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
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
Advanced 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
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Hampton Roads Institution for Performance and Sports Medicine
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23707
Country
United States
Facility Name
McGuire VA Medical Center
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
VAMC Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Health Sciences Centre Pain Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
AIM Health Group London North
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 4E7
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1 W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

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