Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Completed · Phase 2 · Has a placebo group

Conditions studied: Diarrhea-predominant Irritable Bowel Syndrome

In brief

This study is being conducted to evaluate in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment and to evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo (PBO).

Key facts

Study ID

NCT03977155

Run by

Boston Pharmaceuticals

People needed

133

Starts

2019-06-04

Expected to finish

2020-05-06

Last updated by the study team

2021-06-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant meets the diagnosis of diarrhea-predominant IBS (IBS-D) subtype based on Rome IV diagnostic criteria within 3 months prior to randomization. On days when the participant experiences IBS symptoms
• 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.

You may not qualify if…

• At the time of screening, participant has a diagnosis of an IBS subtype other than IBS-D, based on Rome IV 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.)

Where it is running

• 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
• Pinnacle Research Group — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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