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A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ORP-101
Placebo
Sponsored by
OrphoMed, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring Irritable Bowel Syndrome, IBS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing and able to comply with protocol, including completion of electronic daily diary as required.
  • Has a diagnosis of IBS-D (Irritable Bowel Syndrome with Diarrhea) and meets the Rome IV Criteria, by history, for both IBS and IBS-D.
  • Has abdominal pain intensity score, and stool consistency as determined by protocol and assessed by Investigator for the week prior to randomization.
  • Has not used loperamide within the 14 days prior to randomization.
  • Is on a stable diet for the past 12 weeks and is not planning to change lifestyle and/or diet during study.

Exclusion Criteria:

  • History of clinically relevant pancreatic conditions including pancreatitis, pancreas divisum, or Sphincter of Oddi (SO) dysfunction with pancreatic manifestations.
  • History of biliary pathology including acute cholecystitis within 6 months or biliary pain including post-cholecystectomy pain.
  • Patients who have had biliary sphincterotomy with post-procedure persistent abnormal liver function transaminases (LFTs).
  • Planned elective surgery within the next 4 months.
  • Significant and/or severe medical illnesses such as cardiovascular, neurological, infectious, renal, hepatic or respiratory disorders that would interfere with the patient's medical care, participation in, or conduct of the study.
  • History of intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g. aorto-iliac disease).
  • History of lactose intolerance uncontrolled on a lactose-free diet, or other malabsorption syndromes (e.g. fructose malabsorption).
  • Dysphagia or difficulty swallowing pills.
  • History of inflammatory bowel disease, celiac disease, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening.
  • History of major gastric, hepatic, pancreatic or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred > 3 months prior to trial screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred > 3 months prior to screening).
  • Patients >40 years of age at high risk for colon cancer must have had a screening colonoscopy within the past 3 years prior to trial screening visit or > 50 years of age, must have had a normal screening colonoscopy within the past 10 years prior to trial screening visit. Patients with Lynch Syndrome or Familial Polyposis are excluded from the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Achieve Clinical Research (Site 155)
  • Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123)
  • Elite Clinical Studies - Phoenix (Site 116)
  • Del Sol Research Management - BTC (Site 165)
  • Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118)
  • Del Sol Research Management - BTC (Site 130)
  • Preferred Research Partners - ClinEdge (Site 103)
  • Applied Research Center (Site 158)
  • Connecticut Clinical Research Foundation (Site 136)
  • Imagine Research of Palm Beach County (Site 187)
  • Meridien Research - Lakeland (Site 167)
  • Precision Clinical Research LLC (Site 139)
  • Meridien Research, Maitland - Inpatient (Site 141)
  • Oviedo Medical Research (Site 140)
  • Clinical Research Center of Florida (Site 186)
  • Meridien Research - St. Petersburg (Site 132)
  • Agile Clinical Research Trials, LLC (Site 163)
  • Gastrointestinal Diseases, Inc. Research (Site 137)
  • Meridian Clinical Research (Site 169)
  • In Quest Medical Research, LLC (Site 131)
  • GNP Research (Site 145)
  • Northwest Clinical Trials - ClinEdge (Site 133)
  • Synexus Clinical Research US, Inc. - Chicago (Site 120)
  • Investigators Research Group, LLC (Site 188)
  • Synexus Clinical Research US, Inc. - Allaw (Site 102)
  • Alliance for Multispecialty Research, LLC (Site 159)
  • Beth Israel Deaconess Medical Center (Site 115)
  • AES-DRS-Synexus Clinical Research US, Inc.-Minneapolis (site 114)
  • Sundance Clinical Research (Site 175)
  • Synexus Clinical Research US, Inc. - Omaha (Site 113)
  • Synexus Clinical Research US, Inc. - McGill Family Practice, P.C. (Site 126)
  • Jubilee Clinical Research - BTC (Site 162)
  • Sierra Clinical Research (Site 179)
  • Lovelace Scientific Resources Inc. (Site 176)
  • NY Scientific (Site 153)
  • Long Island Gastrointestinal Research Group LLP (Site 107)
  • Synexus Clinical Research US, Inc. - Queens (Site 119)
  • Mid Hudson Medical Research PLLC (Site 174)
  • Upstate Clinical Research Associates LLC - ClinEdge (Site 164)
  • OnSite Clinical Solutions, LLC - ClinEdge (Site 147)
  • OnSite Clinical Solutions, LLC - ClinEdge (Site 146)
  • Peters Medical Research, LLC - ClinEdge (SIte 111)
  • PMG Research of Salisbury LLC (Site 110)
  • PMG Research of Wilmington (Site 185)
  • PMG Research of Winston-Salem (Site 124)
  • Synexus Clinical Research US, Inc. - Akron (Site 122)
  • Hometown Urgent Care and Research (Site 150)
  • Synexus Clinical Research US, Inc. - Cincinnati (Site 127)
  • Synexus Clinical Research US, Inc. - Columbus (Site 108)
  • Hometown Urgent Care and Research (Site 149)
  • Remington Davis Inc (Site 144)
  • PriMed Clinical Research - ClinEdge (Site 121)
  • Hometown Urgent Care and Research (Site 151)
  • Medical Research international (Site 180)
  • Tristar Clinical Investigations, P.C. (Site 168)
  • Frontier Clinical Research, LLC (Site 171)
  • Piedmont Research Partners LLC - BTC (Site 157)
  • Synexus clinical Research US, Inc. - Greer (Site 105)
  • WR-ClinSearch, LLC (Site 129)
  • The Jackson Clinic PA - ClinEdge (Site 135)
  • New Phase Research & Development (Site 181)
  • Benchmark Research - Austin (Site 178)
  • Advanced Medical Trials (SIte 142)
  • Pioneer Research Solutions (Site 125)
  • Synergy Group US, LLC - Missouri City - Hunt (Site 156)
  • DM Clinical Research - LinQ Research - ERN (Site 109)
  • Synexus Clinical Research US, Inc. - San Antonio (Site 112)
  • Clinical Trials of Texas Incorporated - ClinEdge (Site 134)
  • Synexus Clinical Research US, Inc. - Salt Lake City (Site 101)
  • Advanced Research Institute (Site 117)
  • Health Research of Hampton Roads Inc. (Site 173)
  • The Center of Gastrointestinal Health (Site 152)
  • Northwest Clinical Research Center - ClinEdge (Site 148)
  • Exemplar Research, Inc. - Morgantown (Site 172)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ORP-101 50 mg

ORP-101 100 mg

Placebo

Arm Description

ORP-101 (50 mg) once daily

ORP-101 (100 mg), once daily

Matching placebo, once daily

Outcomes

Primary Outcome Measures

Percentage of Participants Who Are Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
Composite responders are defined as participants who met the daily response criteria for at least 50% of the days with diary entries over the 12-week interval. A participant must meet both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Average of daily stool consistency response for all reported bowel movements on the specific day: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain.

Secondary Outcome Measures

Percentage of Participants Who Are Responders in Daily Worst Abdominal Pain Scores
Pain responders over the interval from Weeks 1-12 are defined as those patients who meet the daily pain response criteria for at least 50% of days with diary entry during the interval. To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the 12-week interval.
Percentage of Participants Who Are Responders in Daily Stool Consistency Scores
Stool consistency responders over the interval from Weeks 1-12 are defined as those patients who meet the daily stool consistency response criteria for at least 50% of days with diary entry during the interval. To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the 12-week interval.
Percentage of Participants Who are Responders in IBS Global Symptom Scores
IBS Global Symptom Score: Change from baseline for interval from Weeks 1-12: A responder is defined as a patient who has an IBS global symptom score of 0 (none) or 1 (mild) or daily IBS symptom score improved by ≥ 2.0 compared to the average in the week prior to randomization. A minimum of 60 days of diary entries over the 12-week interval is required for responders.
Percentage of Participants Who are Responders in IBS Adequate Relief Scores
IBS Adequate Relief: Percent of responders over the interval from Weeks 1-12. Responders are defined as those patients with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval.
Percentage of Participants Who Are Modified Composite Responders Based on Responder Endpoints
A modified composite responder endpoint in which a daily responder will be defined as having both: 1) Pain response: worst abdominal pain score in the past 24 hours improved ≥ 30% compared to the average in the week prior to randomization. 2) Stool consistency response: all bowel movements on the specific day must have BSFS score < 5 or the absence of a bowel movement if accompanied by ≥ 30% improvement in worst abdominal pain.
Change from Baseline in Daily Abdominal Discomfort Scores
Discomfort: Change from baseline in daily abdominal discomfort scores
Change from Baseline in Daily Abdominal Bloating Scores
Bloating: Change from baseline in daily abdominal bloating scores
Number of Bowel Movements Per Day
Frequency: Change from baseline in mean number of bowel movements per day
Number of Bowel Incontinence Free Days
Change from baseline in mean number of bowel incontinence episodes per day as well as the number of incontinence-free days

Full Information

First Posted
October 15, 2019
Last Updated
March 3, 2022
Sponsor
OrphoMed, Inc.
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT04129619
Brief Title
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrphoMed, Inc.
Collaborators
PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The objectives of this study are to evaluate the efficacy, safety and tolerability of ORP-101 in patients with IBS-D. This is a randomized, double-blind, placebo-controlled, 3-arm, 12-week, parallel proof-of-concept study with 2 active arms (50 mg and 100 mg ORP-101, QD) and 1 matching placebo arm, using a responsive adaptive randomization approach. After screening, patients who qualify will enter the baseline symptom assessment period, during which they will be instructed on completion of an electronic diary for daily collection of data related to their IBS symptoms, bowel function and loperamide rescue usage (not allowed during baseline). Patients who meet all entry criteria will be randomized to receive one of two different doses of ORP-101 tablets or placebo for 12 weeks. The study drug will be taken once daily, approximately 30 minutes prior to breakfast. Patients will return to the clinic on Days 14, 28, 56, 84 (12 weeks) and 2 weeks after dosing has completed (Day 98) for a follow-up visit. Study subjects will include both male and female adults. Approximately 320 patients with IBS-D will be randomized to receive study drug or placebo. Randomization will be stratified by history of cholecystectomy/gallbladder agenesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
Keywords
Irritable Bowel Syndrome, IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORP-101 50 mg
Arm Type
Experimental
Arm Description
ORP-101 (50 mg) once daily
Arm Title
ORP-101 100 mg
Arm Type
Experimental
Arm Description
ORP-101 (100 mg), once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, once daily
Intervention Type
Drug
Intervention Name(s)
ORP-101
Other Intervention Name(s)
dibuprenorphine-ethyl-ether
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Percentage of Participants Who Are Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
Description
Composite responders are defined as participants who met the daily response criteria for at least 50% of the days with diary entries over the 12-week interval. A participant must meet both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Average of daily stool consistency response for all reported bowel movements on the specific day: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Are Responders in Daily Worst Abdominal Pain Scores
Description
Pain responders over the interval from Weeks 1-12 are defined as those patients who meet the daily pain response criteria for at least 50% of days with diary entry during the interval. To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the 12-week interval.
Time Frame
Week 12
Title
Percentage of Participants Who Are Responders in Daily Stool Consistency Scores
Description
Stool consistency responders over the interval from Weeks 1-12 are defined as those patients who meet the daily stool consistency response criteria for at least 50% of days with diary entry during the interval. To be eligible to be a responder, a patient must have a minimum of 60 days of diary entries over the 12-week interval.
Time Frame
Baseline to Week 12
Title
Percentage of Participants Who are Responders in IBS Global Symptom Scores
Description
IBS Global Symptom Score: Change from baseline for interval from Weeks 1-12: A responder is defined as a patient who has an IBS global symptom score of 0 (none) or 1 (mild) or daily IBS symptom score improved by ≥ 2.0 compared to the average in the week prior to randomization. A minimum of 60 days of diary entries over the 12-week interval is required for responders.
Time Frame
Week 12
Title
Percentage of Participants Who are Responders in IBS Adequate Relief Scores
Description
IBS Adequate Relief: Percent of responders over the interval from Weeks 1-12. Responders are defined as those patients with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval.
Time Frame
Week 12
Title
Percentage of Participants Who Are Modified Composite Responders Based on Responder Endpoints
Description
A modified composite responder endpoint in which a daily responder will be defined as having both: 1) Pain response: worst abdominal pain score in the past 24 hours improved ≥ 30% compared to the average in the week prior to randomization. 2) Stool consistency response: all bowel movements on the specific day must have BSFS score < 5 or the absence of a bowel movement if accompanied by ≥ 30% improvement in worst abdominal pain.
Time Frame
Week 12
Title
Change from Baseline in Daily Abdominal Discomfort Scores
Description
Discomfort: Change from baseline in daily abdominal discomfort scores
Time Frame
Week 12
Title
Change from Baseline in Daily Abdominal Bloating Scores
Description
Bloating: Change from baseline in daily abdominal bloating scores
Time Frame
Week 12
Title
Number of Bowel Movements Per Day
Description
Frequency: Change from baseline in mean number of bowel movements per day
Time Frame
Week 12
Title
Number of Bowel Incontinence Free Days
Description
Change from baseline in mean number of bowel incontinence episodes per day as well as the number of incontinence-free days
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to comply with protocol, including completion of electronic daily diary as required. Has a diagnosis of IBS-D (Irritable Bowel Syndrome with Diarrhea) and meets the Rome IV Criteria, by history, for both IBS and IBS-D. Has abdominal pain intensity score, and stool consistency as determined by protocol and assessed by Investigator for the week prior to randomization. Has not used loperamide within the 14 days prior to randomization. Is on a stable diet for the past 12 weeks and is not planning to change lifestyle and/or diet during study. Exclusion Criteria: History of clinically relevant pancreatic conditions including pancreatitis, pancreas divisum, or Sphincter of Oddi (SO) dysfunction with pancreatic manifestations. History of biliary pathology including acute cholecystitis within 6 months or biliary pain including post-cholecystectomy pain. Patients who have had biliary sphincterotomy with post-procedure persistent abnormal liver function transaminases (LFTs). Planned elective surgery within the next 4 months. Significant and/or severe medical illnesses such as cardiovascular, neurological, infectious, renal, hepatic or respiratory disorders that would interfere with the patient's medical care, participation in, or conduct of the study. History of intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g. aorto-iliac disease). History of lactose intolerance uncontrolled on a lactose-free diet, or other malabsorption syndromes (e.g. fructose malabsorption). Dysphagia or difficulty swallowing pills. History of inflammatory bowel disease, celiac disease, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening. History of major gastric, hepatic, pancreatic or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred > 3 months prior to trial screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred > 3 months prior to screening). Patients >40 years of age at high risk for colon cancer must have had a screening colonoscopy within the past 3 years prior to trial screening visit or > 50 years of age, must have had a normal screening colonoscopy within the past 10 years prior to trial screening visit. Patients with Lynch Syndrome or Familial Polyposis are excluded from the study. Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Achieve Clinical Research (Site 155)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Elite Clinical Studies - Phoenix (Site 116)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Del Sol Research Management - BTC (Site 165)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Del Sol Research Management - BTC (Site 130)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Preferred Research Partners - ClinEdge (Site 103)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Applied Research Center (Site 158)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Connecticut Clinical Research Foundation (Site 136)
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Imagine Research of Palm Beach County (Site 187)
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Meridien Research - Lakeland (Site 167)
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Precision Clinical Research LLC (Site 139)
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Meridien Research, Maitland - Inpatient (Site 141)
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Oviedo Medical Research (Site 140)
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Clinical Research Center of Florida (Site 186)
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Meridien Research - St. Petersburg (Site 132)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Agile Clinical Research Trials, LLC (Site 163)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Gastrointestinal Diseases, Inc. Research (Site 137)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Meridian Clinical Research (Site 169)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
In Quest Medical Research, LLC (Site 131)
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
GNP Research (Site 145)
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31605
Country
United States
Facility Name
Northwest Clinical Trials - ClinEdge (Site 133)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Chicago (Site 120)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Investigators Research Group, LLC (Site 188)
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Allaw (Site 102)
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC (Site 159)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Site 115)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
AES-DRS-Synexus Clinical Research US, Inc.-Minneapolis (site 114)
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
Sundance Clinical Research (Site 175)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Omaha (Site 113)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - McGill Family Practice, P.C. (Site 126)
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Jubilee Clinical Research - BTC (Site 162)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Sierra Clinical Research (Site 179)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Lovelace Scientific Resources Inc. (Site 176)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
NY Scientific (Site 153)
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP (Site 107)
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Queens (Site 119)
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Mid Hudson Medical Research PLLC (Site 174)
City
Newburgh
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Upstate Clinical Research Associates LLC - ClinEdge (Site 164)
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
OnSite Clinical Solutions, LLC - ClinEdge (Site 147)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
OnSite Clinical Solutions, LLC - ClinEdge (Site 146)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Peters Medical Research, LLC - ClinEdge (SIte 111)
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
PMG Research of Salisbury LLC (Site 110)
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington (Site 185)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem (Site 124)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Akron (Site 122)
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Hometown Urgent Care and Research (Site 150)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Cincinnati (Site 127)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Columbus (Site 108)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Hometown Urgent Care and Research (Site 149)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Remington Davis Inc (Site 144)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
PriMed Clinical Research - ClinEdge (Site 121)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Hometown Urgent Care and Research (Site 151)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Medical Research international (Site 180)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Tristar Clinical Investigations, P.C. (Site 168)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Frontier Clinical Research, LLC (Site 171)
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Piedmont Research Partners LLC - BTC (Site 157)
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Synexus clinical Research US, Inc. - Greer (Site 105)
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
WR-ClinSearch, LLC (Site 129)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
The Jackson Clinic PA - ClinEdge (Site 135)
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
New Phase Research & Development (Site 181)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Benchmark Research - Austin (Site 178)
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Advanced Medical Trials (SIte 142)
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Pioneer Research Solutions (Site 125)
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Synergy Group US, LLC - Missouri City - Hunt (Site 156)
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Facility Name
DM Clinical Research - LinQ Research - ERN (Site 109)
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - San Antonio (Site 112)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
48229
Country
United States
Facility Name
Clinical Trials of Texas Incorporated - ClinEdge (Site 134)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Salt Lake City (Site 101)
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Research Institute (Site 117)
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Health Research of Hampton Roads Inc. (Site 173)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
The Center of Gastrointestinal Health (Site 152)
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23805
Country
United States
Facility Name
Northwest Clinical Research Center - ClinEdge (Site 148)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Exemplar Research, Inc. - Morgantown (Site 172)
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
http://prevailibsdstudy.com
Description
For potential patients/subjects, if interested in the study, please visit this website and complete the survey

Learn more about this trial

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

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