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Diarrhea-predominant Irritable Bowel ...

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

Sponsored by Boston Pharmaceuticals

About this trial

Last updated 4 years ago

Study ID

BOS-589-201

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

Inclusion Criteria

- 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.

No

Exclusion Criteria

- 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.)

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