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Completed Phase 3 Interventional Results available

Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

ClinicalTrials.gov ID: NCT01298219

Public ClinicalTrials.gov record NCT01298219. 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, 10:15 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 Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

Brief summary

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

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Study identification

NCT ID
NCT01298219
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sucampo Pharma Americas, LLC
Industry
Enrollment
439 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
Dec 2010 (Type not available)
Primary completion
Nov 2011 (Actual)
Completion
Nov 2011 (Actual)
Last update posted
Feb 11, 2020

2010 – 2011

United States locations

U.S. sites
115
U.S. states
32
U.S. cities
92
Facility City State ZIP Site status
North Alabama Research Center Athens Alabama 35811 —
Innovative Clinical Trials, Inc. Birmingham Alabama 35205 —
Achieve Clinical Research Birmingham Alabama 35216 —
Alabama Clinical Therapeutics Birmingham Alabama 35235 —
G&L Research, LLC Foley Alabama 36535 —
Healthscan Research Montgomery Alabama 36109 —
River Region Research Tallassee Alabama 36078 —
Anasazi Internal Medicine PC Phoenix Arizona 85032 —
Aureas Research, Inc Little Rock Arkansas 72212 —
Certified Clinical Research Carmichael California 95608 —
California Clinical Research, Inc. Davis California 95616 —
Family Medical Center Foothill Ranch California 92610 —
South Orange County Surgical Medical Group Laguna Hills California 92653 —
Clinical Trials Research Lincoln California 95648 —
Clear Vision Research Long Beach California 90805 —
Long Beach VA Medical Center Long Beach California 90822 —
Clear Vision Research Los Angeles California 90023 —
Facey Medical Foundation Mission Hills California 91345 —
North County Clinical Research Oceanside California 92056 —
SDS Clinical Trials, Inc. Orange California 92868 —
Probe Clinical Research Corporation Riverside California 92501 —
Probe Clinical Research Corporation - Santa Ana Santa Ana California 92701 —
Westlake Medical Research Westlake Village California 91361 —
Mountain View Clinical Research Denver Colorado 80209 —
Meridien Research Bradenton Florida 34208 —
Coastal Orthopedics & Pain Management Bradenton Florida 34209 —
Florida Research & Testing, LLC Clearwater Florida 33755 —
Avail Clinical Research DeLand Florida 32720 —
S&W Clinical Research Fort Lauderdale Florida 33306 —
Palm Springs Research Institute Hialeah Florida 33012 —
Kendall South Medical Center, Inc. Miami Florida 33175 —
Gastroenterology Group of Naples Naples Florida 34102 —
Physicians Regional Medical Group Naples Florida 34119 —
Ocala Rheumatology Research Center Ocala Florida 34474 —
Paddock Park Clinical Research Ocala Florida 34474 —
Journey Research, Inc. Oldsmar Florida 34677 —
Compass Research Orlando Florida 32806 —
Andres Patron, DO, PA Pembroke Pines Florida 30026 —
Advent Clinical Research Centers Pinellas Park Florida 33781 —
Gold Coast Research, LLC Plantation Florida 33317 —
Orthopedic Research Institite Royal Palm Beach Florida 33411 —
IC Research Sanford Florida 32771 —
Sarasota Memorial Pain Care Center Sarasota Florida 34238 —
Tampa Clinical Research Tampa Florida 33624 —
Southeastern Regional Research Group Columbus Georgia 31904 —
Better Health Clinical Research Newnan Georgia 30265 —
Clinical Research Atlanta Stockbridge Georgia 30281 —
Advanced Clinical Research Boise Idaho 83642 —
Sonora Clinical Research Boise Idaho 83702 —
Nautical Clinical Research Meridian Idaho 83642 —
Anesthesia/Pain Control Indiana University School of Medicine Chicago Illinois 60657 —
Knight Center for Integrated Health Peoria Illinois 61614 —
Ridge Family Practice Council Bluffs Iowa 51503 —
Lee Research Institute Lenexa Kansas 66215 —
Kentucky Medical Research Center Lexington Kentucky 40504 —
Bluegrass Internal Medicine Owensboro Kentucky 42303 —
Horizon Research Group Baton Rouge Louisiana 70809 —
Miray Medical Center Brockton Massachusetts 02301 —
The Research Institute Springfield Massachusetts 01107 —
Coastal Research Weymouth Massachusetts 02190 —
Ashok Jain, MD Dearborn Michigan 48124 —
Shores Medical Associates Saint Clair Shores Michigan 48081 —
Mid-America Clinical Research LLC St Louis Missouri 63139 —
Montana Medical Research, Inc. Missoula Montana 59808 —
Independent Clinical Researchers Las Vegas Nevada 89106 —
AB Clinical Trials Las Vegas Nevada 89119 —
Clinical Research of South Nevada Las Vegas Nevada 89121 —
Clinical Research Advantage, Inc. Las Vegas Nevada 89128 —
Lab2Marche Las Vegas Nevada 89149 —
Aloha Medical Center Las Vegas Nevada 89183 —
Edison Medical Group Edison New Jersey 08817 —
Clinical Research Program Marlton New Jersey 08053 —
Albuquerque Clinical Trials Albuquerque New Mexico 87102 —
Drug Trials America Hartsdale New York 10530 —
Family Health Medical Services PLLC Jamestown New York 14701 —
U of Rochester Rochester New York 14618 —
Medical Frontiers Carlisle Ohio 45005 —
Hightop Medical Research Center Cincinnati Ohio 45224 —
Community Research Cincinnati Ohio 45227 —
Community Research Cincinnati Ohio 45245 —
Rapid Medical Research, Inc. Cleveland Ohio 44122 —
Parsons Avenue Medical Center Columbus Ohio 43207 —
Hometown Urgent Care Groveport Ohio 43125 —
Northstar Medical Research, LLC Middleburg Heights Ohio 44130 —
Pharmacotherpy Research Associates Inc Zanesville Ohio 43701 —
COR Clinical Research, LLC Oklahoma City Oklahoma 73103 —
Sooner Clinical Research Oklahoma City Oklahoma 73112 —
Sunstone Medical Research Medford Oregon 97504 —
Fanno Creek Clinic Portland Oregon 97219 —
McMillen & Magargle Mechanicsburg Pennsylvania 17055 —
Omega Medical Research Warwick Rhode Island 02886 —
Hartwell Research Group Anderson South Carolina 29621 —
Degarmo Institute of Medical Research Greer South Carolina 29651 —
Pain Specialists of Charleston North Charleston South Carolina 29406 —
Health Concepts Rapid City South Dakota 57702 —
InvestiClin Research Brentwood Tennessee 37027 —
SCRI Research Center Germantown Tennessee 38138 —
Prevention & Strengthening Solutions, Inc. Humboldt Tennessee 38343 —
FutureSearch Trials of Neurology & Sleep Lab Austin Texas 78756 —
Jaron Winston, MD Austin Texas 78757 —
KRK Medical Research Dallas Texas 75230 —
FutureSearch Trials of Dallas, LP Dallas Texas 75231 —
Pillar Clinical Research, LLC Dallas Texas 75243 —
Galenos Research Dallas Texas 75251 —
Diversified Medical Practice, P.A. Houston Texas 77027 —
Clinical Trial Network Houston Texas 77074 —
Dependable Clinical Research Houston Texas 77074 —
Pioneer Research Solutions, Inc. Houston Texas 77098 —
Bobby Huynh Richardson Texas 75080 —
Sun Research Institute San Antonio Texas 78215 —
Spring Clinical Research Sugar Land Texas 77478 —
Pioneer Research Solutions Sugar Land Texas 77479 —
Lifetree Clinical Research Salt Lake City Utah 84106 —
ACR Research Salt Lake City West Jordan Utah 84088 —
Virginia Research Center, LLC Midlothian Virginia 23114 —

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 27 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01298219, 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 Feb 11, 2020 · 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 NCT01298219 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →