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ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

ClinicalTrials.gov ID: NCT00597428

Public ClinicalTrials.gov record NCT00597428. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 11:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).

Study identification

NCT ID
NCT00597428
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sucampo Pharma Americas, LLC
Industry
Enrollment
437 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2007 (Type not available)
Primary completion
Mar 2009 (Actual)
Completion
Mar 2009 (Actual)
Last update posted
Dec 10, 2019

2007 – 2009

United States locations

U.S. sites
109
U.S. states
33
U.S. cities
96
Facility City State ZIP Site status
Tuscaloosa VA Medical Center Tuscaloosa Alabama 35404 —
Carl T Hayden VA Medical Center Phoenix Arizona 85012 —
Redpoint Research Phoenix Arizona 85029 —
HOPE Research Institute, LLC Phoenix Arizona 85050 —
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC Tempe Arizona 85222 —
Premiere Pharamaceutical Research, LLC Tempe Arizona 85282 —
Harmony Clinical Research, Inc. Tucson Arizona 85705 —
Martin Bowen Hefley Knee Little Rock Arkansas 72205 —
Advanced Pain Institute Arcadia California 91007 —
Pain Institute of CA Bakersfield California 93311 —
Catalina Research Institute, LLC Chino California 91710 —
California Pain Center Huntington Beach California 92647 —
Shreenath Clinical Service Laguna Hills California 92637 —
Loma Linda University Physicians Medical Group Loma Linda California 92354 —
VA Long Beach Healthcare System Long Beach California 90822-5201 —
Rider Research Group San Francisco California 94117 —
Clinicos, LLC Colorado Springs Colorado 80904 —
Rocky Mountain Gastroenterology Associates Lakewood Colorado 80215 —
Arapahoe Gastroenterology, PC Littleton Colorado 80120 —
Metro Clinical Research, LLC Littleton Colorado 80122 —
Clinical Trial Management of Boca Raton, Inc. Boca Raton Florida 33486 —
Florida Institute of Medical Research Jacksonville Florida 32257 —
Drug Study Institute Jupiter Florida 33458 —
Gastroenterology Group of Naples Naples Florida 34102 —
Kenneth W. Ponder, MD PA Niceville Florida 32578 —
North Miami Research, Inc. North Miami Florida 33161 —
Renstar Inc. Ocala Florida 34471 —
Peninsula Research, Inc Ormond Beach Florida 32174 —
DMI Research, Inc. Pinellas Park Florida 33782 —
Sunrise Medical Research, Inc. Plantation Florida 33324 —
Accord Clinical Research, LLC Port Orange Florida 32129 —
Lovelace Scientific Resources, Inc. Sarasota Florida 34233 —
Meridien Research St. Petersburg Florida 33709 —
Clinical Research of West Florida, Inc. Tampa Florida 33603 —
Stedman Clinical Trials Tampa Florida 33613 —
Advanced Pain Management Augusta Georgia 30901 —
Global Research Partners & Consultants, Incs. Calhoun Georgia 30701 —
Q Clinical Research Decatur Georgia 30035 —
Apex Medical Research, AMR, Inc. Chicago Illinois 60616 —
Claude Mandel Medical Center Chicago Illinois 60617 —
Advanced Pain Care Clinic Evansville Indiana 47630 —
MediSphere Medical Research Center Evansville Indiana 47714 —
Davis Clinic, PC Indianapolis Indiana 46260 —
University of Kansas Medical Center Kansas City Kansas 66160 —
University of Louisville Louisville Kentucky 40202 —
Gulf Coast Research, LLC Lafayette Louisiana 70503 —
Delta Research Partners, LLC Monroe Louisiana 71201 —
Louisiana Research Center, LLC Shreveport Louisiana 71103 —
Rehabilitation Team West, PA Baltimore Maryland 21228 —
Columbia Medical Practice/ RxTrials, Inc. Columbia Maryland 21045 —
Washington County Hospital Association - The Center for Clinical Research Hagerstown Maryland 21742 —
Beth Israel Deaconess Medical Center, Harvard Medical School Boston Massachusetts 02215 —
MedVadis Research Corporation Wellesley Hills Massachusetts 02481 —
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047 —
Professional Clinical Research, Inc. Interlochen Michigan 49643 —
PCM Medical Services Lansing Michigan 48917 —
Women's Health Care Specialists, PC Paw Paw Michigan 49079 —
Medical Research Associates Traverse City Michigan 49684 —
Center for Digestive Health Troy Michigan 48098 —
MAPS Applied Research Center Edina Minnesota 55435 —
Mayo Clinic Rochester Minnesota 55905 —
Precise Research, Inc. Flowood Mississippi 39232 —
Medex Healthcare Research St Louis Missouri 63117 —
Montana Neuroscience Institute Foundation / Montana Spine and Pain Center Missoula Montana 59802 —
Creighton University Medical Center Omaha Nebraska 68131 —
Advanced Biomedical Research of America Las Vegas Nevada 89123 —
Lovelace Scientific Resources, Inc. Las Vegas Nevada 89146 —
Gastroenterology Research Associates Cedar Knolls New Jersey 07927 —
Central Jersey Medical Research Center Elizabeth New Jersey 07202 —
Holy Name Hospital, Institute for Clinical Research Teaneck New Jersey 07666 —
Advanced Pain Consultants Voorhees Township New Jersey 08043 —
Medex Healthcare Research, Inc. New York New York 10004 —
New York University Pain Management Center New York New York 10016 —
Research Across America New York New York 10022 —
North American Partners Valley Stream New York 11580 —
Upstate Clinical Research Associates Williamsville New York 14221 —
Randolph Medical Associates Asheboro North Carolina 27203 —
Duke University Medical Center Durham North Carolina 27710 —
Carolina Research Greenville North Carolina 27834 —
Carolina Digestive Health Associates Harrisburg North Carolina 28075 —
Peters Medical Research, LLC High Point North Carolina 27262 —
Triangle Medical Research Lexington North Carolina 27295 —
Southern Gastroenterology Associates New Bern North Carolina 28562 —
Valley Medical Primary Care Centerville Ohio 45459 —
Glenway Family Medicine Cincinnati Ohio 45238 —
The Ohio State University Medical Center Columbus Ohio 43210-1228 —
Urgent Care Specialists Dayton Ohio 45432 —
RAS Health Ltd. Marion Ohio 43302 —
University of Toledo - Health Science Campus Toledo Ohio 43614 —
Lynn Health Science Institute Oklahoma City Oklahoma 73112 —
Paradigm Research Professionals, LLP Oklahoma City Oklahoma 73112 —
Memorial Clinical Research Oklahoma City Oklahoma 73134 —
Medford Medical Clinic, LLP Medford Oregon 97504 —
Lehigh Valley Hospital - Neurosciences and Pain Research Allentown Pennsylvania 18103 —
Einstein Pain Institute Philadelphia Pennsylvania 19414 —
Jeffry A. Lindenbaum DO, PC Yardley Pennsylvania 19067 —
Baptist Medical Tower Suite 740 Knoxville Tennessee 37920 —
Integrity Clinical Research, LLC Milan Tennessee 38358 —
Texas Familicare Clinical Research Hurst Texas 76054 —
DCOL Center for Clinical Research Longview Texas 75605 —
Bexar Clinical Trials, LLC Richardson Texas 75082 —
Advance Research Institute Ogden Utah 84405 —
Highland Clinical Research Salt Lake City Utah 84124 —
University of Utah Salt Lake City Utah 84132-2410 —
New River Valley Research Institute Christiansburg Virginia 24073 —
Hampton Roads Institute for Performance and Sports Medicine (HIPS) Portsmouth Virginia 23707 —
McGuire Research Institute Richmond Virginia 23249 —
Northwest Gastroenterology Associates Bellevue Washington 98004 —
Daniel R. Coulston Spokane Washington 99204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00597428, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 10, 2019 · Synced Oct 26, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00597428 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →