ClinicalTrials.gov record
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.
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)
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
Conditions
Interventions
- Lubiprostone Drug
- Placebo Drug
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
- Jul 31, 2007
- Primary completion
- Feb 28, 2009
- Completion
- Feb 28, 2009
- Last update posted
- Dec 9, 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 9, 2019 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT00597428 live on ClinicalTrials.gov.