Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
NCT ID: NCT03977155
Last Updated: 2021-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2019-06-04
2020-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High dose of BOS-589
Participants will receive a high dose of BOS-589 orally twice a day (BID).
BOS-589
oral tablets
Low dose of BOS-589
Participants will receive a low dose of BOS-589 orally BID.
BOS-589
oral tablets
Placebo
Participants will receive matching placebo orally BID.
Placebo
oral tablets
Interventions
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BOS-589
oral tablets
Placebo
oral tablets
Eligibility Criteria
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Inclusion Criteria
* At least 25% of stools are loose or watery; and
* Fewer than 25% of stools are hard.
* Recurrent abdominal pain occurring, on average, at least 1 day per week and associated with 2 or more of the following:
* Related to defecation;
* Associated with a change in frequency of bowel movements;
* Associated with a change in form (appearance) of stool.
* Over the week prior to randomization, the participant has
* An average of worst abdominal pain (WAP) scores in the prior 24 hours of 4.0 to 8.0 on a 0 to 10 numerical rating scale;
* An average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 (and at least 5 days with a BSFS score ≥ 5.0;
* An average daily IBS-Global Scale (IBS-GS) score of ≥ 2.0.
* Participant must undergo or previously have undergone (a) an appropriate evaluation for their IBS symptoms, including an evaluation for organic/structural etiologies (if in the presence of alarm symptoms); and (b) age-appropriate screening for colorectal cancer, if applicable.
* Participant is negative for serum tissue transglutaminase immunoglobulin A antibody (tTG-IgA) plus has evidence of detectable serum IgA within the normal reference range.
Exclusion Criteria
* Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including (but not limited to) inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, microscopic colitis, and celiac disease).
* Participant has had an episode of diverticulitis within 3 months prior to Screening.
* Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aortoiliac occlusive disease).
* Participant has any of the following surgical history:
* Cholecystectomy with any history of post-cholecystectomy biliary tract pain;
* Any abdominal surgery within the 3 months prior to Screening;
* Major gastric, esophageal, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
* Confirmed alanine aminotransferase (ALT) \> 2 upper limit of normal (ULN)
* Confirmed total bilirubin \> ULN, unless the participant has a documented history of Gilbert's syndrome
* Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or Human immunodeficiency virus (HIV)-1 or HIV-2 antibody positive
* Evidence of HCV infection based on a positive HCV antibody screen (Participants who have been successfully treated for HCV are eligible if an undetectable HCV viral load at least 6 months after completion of treatment can be demonstrated.)
18 Years
65 Years
ALL
No
Sponsors
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Boston Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Phoenix Southeast
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Hope Research Institute LLC
Peoria, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Synexus Clinical Research US, Inc. - Tatum Highlands Medical Associates, PLLC
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Synexus Clinical Research US, Inc.
Carlsbad, California, United States
Paragon Rx Clinical, Inc.
Garden Grove, California, United States
eStudySite
La Mesa, California, United States
Grossmont Center For Clinical Research
La Mesa, California, United States
Clinical Trials Research
Sacramento, California, United States
Research and Education Inc
San Diego, California, United States
Precision Research Institute
San Diego, California, United States
Shahram Jacobs MD Inc
Sherman Oaks, California, United States
Millennium ClinicalTrials
Thousand Oaks, California, United States
Advanced Rx Clinical Research
Westminster, California, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
PAB Clinical Research-ClinEdge-PPDS
Brandon, Florida, United States
Nature Coast Clinical Research LLC - ERN-PPDS
Inverness, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Health Awareness Inc
Jupiter, Florida, United States
Suncoast Research Group LLC - ERN-PPDS
Miami, Florida, United States
Ormond Medical Arts Pharmaceutical
Ormond Beach, Florida, United States
Precision Clinical Research, LLC
Sunrise, Florida, United States
Northwest Clinical Trials-ClinEdge-PPDS
Boise, Idaho, United States
Synexus Clinical Research US, Inc. - Allaw
Evansville, Indiana, United States
Boston Clinical Trials Inc
Boston, Massachusetts, United States
West Michigan Clinical Research
Wyoming, Michigan, United States
Sundance Clinical Research
St Louis, Missouri, United States
Quality Clinical Research - ClinEdge - PPDS
Omaha, Nebraska, United States
Albuquerque Clinical Trials Inc - BTC - PPDS
Albuquerque, New Mexico, United States
NY Scientific
Brooklyn, New York, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
Synexus Clinical Research US, Inc.
Akron, Ohio, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, United States
Synexus Clinical Research US, Inc.
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Founders Research Corporation
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States
Pledmont Research Partners LLC
Fort Mill, South Carolina, United States
Synexus Clinical Research US, Inc.
Greer, South Carolina, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
New Phase Research & Development
Knoxville, Tennessee, United States
L12 Clinical Research
Dallas, Texas, United States
Synexus Clinical Research US, Inc.
Dallas, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BOS-589-201
Identifier Type: -
Identifier Source: org_study_id
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