search
Back to results

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 (OBD) 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 inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (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:

  • 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).
  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
  • 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.
  • Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.

Sites / Locations

  • The Birmingham Pain Center
  • Simon Williamson Clinic, PC
  • Alabama Orthopedic Clinic
  • Clinical Research Advantage, Inc./ Mesa Family Medical Center
  • Clinical Research Advantage, Inc.
  • Harmony Clinical Research, Inc.
  • Verona Clinical Research, Inc.
  • Quality of Life Medical & Research Center, LLC
  • Genova Clinical Research, Inc.
  • Pusch Ridge Family Medicine / WC Clinical Research
  • Advanced Clinical Research Institute
  • Orange County Clinical Trials, Inc.
  • Gregory J. Wiener, MD PC
  • Digestive and Liver Disease Specialists
  • RX Clinical Research, Inc
  • Physicians Clinical Research Corporation
  • Loma Linda University Physicians Medical Group
  • HealthCare Partners Medical Group
  • Impact Clinical Trials
  • The Regents of the University of California, Los Angeles
  • Pasadena Rehabilitation Institute
  • Northern California Research Corporation
  • SB Family Medicine
  • Lynn Institute of the Rockies
  • Lynn Institute of Pueblo
  • Advanced Diagnostic Pain Treatment Center
  • International Research Clinicians of Conneticut
  • New England Research Associates, LLC
  • Meridien Research
  • South Lake Pain Institute
  • Century Clinical Research
  • International Medical Research
  • Clinical Physiology Associates/Clinical Study Center
  • Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute
  • Palm Beach Research Center
  • North Georgia Premier Research
  • Best Clinical Research
  • Drug Studies America
  • Pinnacle Trials Inc.
  • Rosemark Women Care Specialists
  • Saltzer Medical Group
  • Millenium Pain Center
  • University of Illinois Medical Center
  • Redhead Research Inc., dba Research Associates of Central Illinois
  • Integrated Clinical Trial Services, Inc.
  • The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC
  • Gulf Coast Research, LLC
  • Tulane University Health Sciences Center
  • The Willis-Knighton Pain Management Center
  • Pain and Rehabilitation Medicine
  • The Brigham and Women's Hospital
  • Professional Clinical Research, Benzonia
  • Center for Clinical Studies
  • Apex Medical Research, AMR, Inc.
  • Digestive Health Specialists, PA
  • Impact Clinical Trials, Las Vegas
  • Office of Stephen H. Miller, MD
  • University of Nevada
  • Cooper Health System
  • UMDNJ
  • Partners in Primary Care
  • Abraham D. Morganoff, MD PA
  • Northway Medical Associates
  • Long Island Clinical Research Associates, LLP
  • Long Island Gastrointestinal Research Group
  • University of Rochester
  • Diversified Research
  • Medoff Medical/ Vital re:Search
  • Carolina Pharmaceutical Research
  • Center for Clinical Research, LLC
  • St. Alexius Medical Center
  • Cleveland Clinic
  • COR Clinical Research, LLC
  • Pain Research of Oregon, LLC
  • Affinity Research
  • Private Practice of Dr. Hasan
  • University of Pittsburgh Medical Center
  • Preferred Primary Care Physicians
  • Partners in Clinical Research
  • University Gastroenterology
  • Trident Institute of Medical Research, LLC
  • Southeastern Clinical Research
  • Comprehensive Pain Specialists, PLLC
  • Vanderbilt University - Interventional Pain Center
  • Integrity Clinical Research, LLC
  • Dallas VA Research Corporation, Inc.
  • Bexar Clinical Trials, LLC
  • Permian Research Foundation
  • Bexar Clinical Trials, LLC
  • Salt Lake Research, PLLC
  • Digestive and Liver Disease Specialists
  • General Clinical Research Center, Virginia Commonwealth University, North Hospital
  • Metro Physicians a Division of Wheaton Franciscan Medical Group
  • Clement J. Zablocki VA Medical Center
  • Health Sciences Center

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

Mean Weekly Spontaneous Bowel Movements at Week 8
Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.

Secondary Outcome Measures

Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks
Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12
Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose
The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.
Number of Participants Classified as Responders
Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.
Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline. Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best; Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse
Participant Reported Outcome of Treatment Effectiveness
Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.

Full Information

First Posted
January 4, 2008
Last Updated
December 6, 2019
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00595946
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
December 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.

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
439 (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
Mean Weekly Spontaneous Bowel Movements at Week 8
Description
Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.
Time Frame
at Week 8
Secondary Outcome Measure Information:
Title
Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks
Description
Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12
Time Frame
within 12 weeks
Title
Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose
Description
The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.
Time Frame
within 48 hours post-dose
Title
Number of Participants Classified as Responders
Description
Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.
Time Frame
within 12 weeks
Title
Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
Description
Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline. Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best; Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse
Time Frame
within 12 weeks
Title
Participant Reported Outcome of Treatment Effectiveness
Description
Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.
Time Frame
within 12 weeks

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 (OBD) 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 inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (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: 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). Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening. Gastrointestinal or abdominal surgical procedures within 90 days prior to screening. Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting. 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. Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team 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
Clinical Research Advantage, Inc.
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
Verona Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710-3539
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
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Pusch Ridge Family Medicine / WC Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Gregory J. Wiener, MD PC
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
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
Physicians Clinical Research Corporation
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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
HealthCare Partners Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Impact Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
The Regents of the University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
SB Family Medicine
City
Solana Beach
State/Province
California
ZIP/Postal Code
92075
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Lynn Institute of Pueblo
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81001
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
International Research Clinicians of Conneticut
City
Ridgefield
State/Province
Connecticut
ZIP/Postal Code
06877
Country
United States
Facility Name
New England Research Associates, LLC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
South Lake Pain Institute
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Century Clinical Research
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
Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
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
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
Pinnacle Trials Inc.
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Saltzer Medical Group
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
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 Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Redhead Research Inc., dba Research Associates of Central Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Integrated 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 and Ballard Wright, MD PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Gulf Coast Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
The Willis-Knighton Pain Management Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Pain and Rehabilitation Medicine
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
The Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Professional Clinical Research, Benzonia
City
Benzonia
State/Province
Michigan
ZIP/Postal Code
49616
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
Digestive Health Specialists, PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Impact Clinical Trials, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
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
University of Nevada
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States
Facility Name
Cooper Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
UMDNJ
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Partners in Primary Care
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Abraham D. Morganoff, MD PA
City
Watchung
State/Province
New Jersey
ZIP/Postal Code
07069
Country
United States
Facility Name
Northway Medical Associates
City
Fulton
State/Province
New York
ZIP/Postal Code
13069
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
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
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Diversified Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Medoff Medical/ Vital re:Search
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Carolina Pharmaceutical Research
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
St. Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Pain Research of Oregon, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Affinity Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Private Practice of Dr. Hasan
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Partners in Clinical Research
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
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
Vanderbilt University - Interventional Pain Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Savannah
State/Province
Tennessee
ZIP/Postal Code
38372
Country
United States
Facility Name
Dallas VA Research Corporation, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Bexar Clinical Trials, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Permian Research Foundation
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Bexar Clinical Trials, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Facility Name
Salt Lake Research, PLLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
General Clinical Research Center, Virginia Commonwealth University, North Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Metro Physicians a Division of Wheaton Franciscan Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States
Facility Name
Clement J. Zablocki VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Health Sciences Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24716835
Citation
Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.
Results Reference
derived

Learn more about this trial

Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

We'll reach out to this number within 24 hrs