ClinicalTrials.gov record
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
ClinicalTrials.gov ID: NCT04129619
Public ClinicalTrials.gov record NCT04129619. 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 Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ORP-101 in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D.
Study identification
- NCT ID
- NCT04129619
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 321 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Nov 22, 2019 (Actual)
- Primary completion
- Oct 4, 2021 (Actual)
- Completion
- Oct 4, 2021 (Actual)
- Last update posted
- Mar 4, 2022
2019 – 2021
United States locations
- U.S. sites
- 74
- U.S. states
- 28
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research (Site 155) | Birmingham | Alabama | 35216 | — |
| Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123) | Chandler | Arizona | 85224 | — |
| Elite Clinical Studies - Phoenix (Site 116) | Phoenix | Arizona | 85018 | — |
| Del Sol Research Management - BTC (Site 165) | Tucson | Arizona | 85712 | — |
| Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118) | Tucson | Arizona | 85741 | — |
| Del Sol Research Management - BTC (Site 130) | Tucson | Arizona | 85745 | — |
| Preferred Research Partners - ClinEdge (Site 103) | Little Rock | Arkansas | 72211 | — |
| Applied Research Center (Site 158) | Little Rock | Arkansas | 72212 | — |
| Connecticut Clinical Research Foundation (Site 136) | Bristol | Connecticut | 06010 | — |
| Imagine Research of Palm Beach County (Site 187) | Boynton Beach | Florida | 33435 | — |
| Meridien Research - Lakeland (Site 167) | Lakeland | Florida | 33803 | — |
| Precision Clinical Research LLC (Site 139) | Lauderdale Lakes | Florida | 33319 | — |
| Meridien Research, Maitland - Inpatient (Site 141) | Maitland | Florida | 32751 | — |
| Oviedo Medical Research (Site 140) | Oviedo | Florida | 32765 | — |
| Clinical Research Center of Florida (Site 186) | Pompano Beach | Florida | 33060 | — |
| Meridien Research - St. Petersburg (Site 132) | St. Petersburg | Florida | 33709 | — |
| Agile Clinical Research Trials, LLC (Site 163) | Atlanta | Georgia | 30328 | — |
| Gastrointestinal Diseases, Inc. Research (Site 137) | Columbus | Georgia | 31904 | — |
| Meridian Clinical Research (Site 169) | Savannah | Georgia | 31406 | — |
| In Quest Medical Research, LLC (Site 131) | Suwanee | Georgia | 30024 | — |
| GNP Research (Site 145) | Valdosta | Georgia | 31605 | — |
| Northwest Clinical Trials - ClinEdge (Site 133) | Boise | Idaho | 83704 | — |
| Synexus Clinical Research US, Inc. - Chicago (Site 120) | Chicago | Illinois | 60602 | — |
| Investigators Research Group, LLC (Site 188) | Brownsburg | Indiana | 46112 | — |
| Synexus Clinical Research US, Inc. - Allaw (Site 102) | Evansville | Indiana | 47714 | — |
| Alliance for Multispecialty Research, LLC (Site 159) | Wichita | Kansas | 67207 | — |
| Beth Israel Deaconess Medical Center (Site 115) | Boston | Massachusetts | 02215 | — |
| AES-DRS-Synexus Clinical Research US, Inc.-Minneapolis (site 114) | Richfield | Minnesota | 55423 | — |
| Sundance Clinical Research (Site 175) | St Louis | Missouri | 63141 | — |
| Synexus Clinical Research US, Inc. - Omaha (Site 113) | Omaha | Nebraska | 68144 | — |
| Synexus Clinical Research US, Inc. - McGill Family Practice, P.C. (Site 126) | Papillion | Nebraska | 68046 | — |
| Jubilee Clinical Research - BTC (Site 162) | Las Vegas | Nevada | 89106 | — |
| Sierra Clinical Research (Site 179) | Las Vegas | Nevada | 89106 | — |
| Lovelace Scientific Resources Inc. (Site 176) | Albuquerque | New Mexico | 87108 | — |
| NY Scientific (Site 153) | Brooklyn | New York | 11235 | — |
| Long Island Gastrointestinal Research Group LLP (Site 107) | Great Neck | New York | 11023 | — |
| Synexus Clinical Research US, Inc. - Queens (Site 119) | Jamaica | New York | 11432 | — |
| Mid Hudson Medical Research PLLC (Site 174) | Newburgh | New York | 12553 | — |
| Upstate Clinical Research Associates LLC - ClinEdge (Site 164) | Williamsville | New York | 14221 | — |
| OnSite Clinical Solutions, LLC - ClinEdge (Site 147) | Charlotte | North Carolina | 28210 | — |
| OnSite Clinical Solutions, LLC - ClinEdge (Site 146) | Charlotte | North Carolina | 28277 | — |
| Peters Medical Research, LLC - ClinEdge (SIte 111) | High Point | North Carolina | 27262 | — |
| PMG Research of Salisbury LLC (Site 110) | Salisbury | North Carolina | 28144 | — |
| PMG Research of Wilmington (Site 185) | Wilmington | North Carolina | 28401 | — |
| PMG Research of Winston-Salem (Site 124) | Winston-Salem | North Carolina | 27103 | — |
| Synexus Clinical Research US, Inc. - Akron (Site 122) | Akron | Ohio | 44311 | — |
| Hometown Urgent Care and Research (Site 150) | Cincinnati | Ohio | 45215 | — |
| Synexus Clinical Research US, Inc. - Cincinnati (Site 127) | Cincinnati | Ohio | 45236 | — |
| Synexus Clinical Research US, Inc. - Columbus (Site 108) | Columbus | Ohio | 43212 | — |
| Hometown Urgent Care and Research (Site 149) | Columbus | Ohio | 43214 | — |
| Remington Davis Inc (Site 144) | Columbus | Ohio | 43215 | — |
| PriMed Clinical Research - ClinEdge (Site 121) | Dayton | Ohio | 45419 | — |
| Hometown Urgent Care and Research (Site 151) | Dayton | Ohio | 45424 | — |
| Medical Research international (Site 180) | Oklahoma City | Oklahoma | 73109 | — |
| Tristar Clinical Investigations, P.C. (Site 168) | Philadelphia | Pennsylvania | 19114 | — |
| Frontier Clinical Research, LLC (Site 171) | Uniontown | Pennsylvania | 15401 | — |
| Piedmont Research Partners LLC - BTC (Site 157) | Fort Mill | South Carolina | 29707 | — |
| Synexus clinical Research US, Inc. - Greer (Site 105) | Greer | South Carolina | 29651 | — |
| WR-ClinSearch, LLC (Site 129) | Chattanooga | Tennessee | 37421 | — |
| The Jackson Clinic PA - ClinEdge (Site 135) | Jackson | Tennessee | 38305 | — |
| New Phase Research & Development (Site 181) | Knoxville | Tennessee | 37909 | — |
| Benchmark Research - Austin (Site 178) | Austin | Texas | 78704 | — |
| Advanced Medical Trials (SIte 142) | Georgetown | Texas | 78628 | — |
| Pioneer Research Solutions (Site 125) | Houston | Texas | 77099 | — |
| Synergy Group US, LLC - Missouri City - Hunt (Site 156) | Missouri City | Texas | 77459 | — |
| DM Clinical Research - LinQ Research - ERN (Site 109) | Pearland | Texas | 77584 | — |
| Synexus Clinical Research US, Inc. - San Antonio (Site 112) | San Antonio | Texas | 48229 | — |
| Clinical Trials of Texas Incorporated - ClinEdge (Site 134) | San Antonio | Texas | 78229 | — |
| Synexus Clinical Research US, Inc. - Salt Lake City (Site 101) | Murray | Utah | 84123 | — |
| Advanced Research Institute (Site 117) | Ogden | Utah | 84405 | — |
| Health Research of Hampton Roads Inc. (Site 173) | Newport News | Virginia | 23606 | — |
| The Center of Gastrointestinal Health (Site 152) | Petersburg | Virginia | 23805 | — |
| Northwest Clinical Research Center - ClinEdge (Site 148) | Bellevue | Washington | 98007 | — |
| Exemplar Research, Inc. - Morgantown (Site 172) | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04129619, 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 Mar 4, 2022 · Synced Oct 24, 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 NCT04129619 live on ClinicalTrials.gov.