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

NCT03977155 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BOS-589-201
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 58

Brief Summary

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).

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; diarrhea; BOS-589

Outcome Measures

Primary Outcomes (2)

• 24-hour Worst Abdominal Pain Scores (WAP) at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point)

  To evaluate in participants with diarrhea-predominant irritable bowel syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment, relative to placebo. Throughout the 4 weeks of the double blind treatment phase, participants were asked to rate their WAP in the past 24 hours. The participant-reported WAP in the past 24 hours was recorded on a 0 to 10 scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. Higher scores indicated worse outcome.

  Baseline; Day 29

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Because of AEs, and Any Treatment-related Severe AEs

  To evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo.

  Up to Day 43/end-of-study follow up visit

Secondary Outcomes (9)

• Change in Stool Consistency, Measured by the Daily Bristol Stool Form Score (BSFS) Most Representative Stool Consistency Scores at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point)

  Baseline; Day 29

• Change in Stool Consistency, Measured by the Daily BSFS Worst (Loosest) Stool Consistency Scores at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point)

  Baseline; Day 29

• Change in Stool Frequency, Measured by the Total Number of Spontaneous Bowel Movements in 24 Hours at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point)

  Baseline; Day 29

• Changes in the Irritable Bowel Syndrome-Severity Score (IBS-SS) at Day 29 Compared to Baseline

  Baseline; Day 29

• Change in the IBS Global Scale (IBS-GS) at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point)

  Baseline; Day 29

Study Arms (3)

High dose of BOS-589

EXPERIMENTAL

Participants will receive a high dose of BOS-589 orally twice a day (BID).

Drug: BOS-589

Low dose of BOS-589

EXPERIMENTAL

Participants will receive a low dose of BOS-589 orally BID.

Drug: BOS-589

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo orally BID.

Drug: Placebo

Interventions

BOS-589 DRUG

oral tablets

High dose of BOS-589; Low dose of BOS-589

Placebo DRUG

oral tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• Boston Pharmaceuticals: lead

Study Sites (58)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Synexus Clinical Research US, Inc. - Phoenix Southeast

Chandler, Arizona, 85224, United States

Location

Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC

Mesa, Arizona, 85018, United States

Location

Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

Mesa, Arizona, 85213, United States

Location

Hope Research Institute LLC

Peoria, Arizona, 85381, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Synexus Clinical Research US, Inc. - Tatum Highlands Medical Associates, PLLC

Phoenix, Arizona, 85050, United States

Location

Hope Research Institute LLC

Phoenix, Arizona, 85206, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Synexus Clinical Research US, Inc.

Carlsbad, California, 95821, United States

Location

Paragon Rx Clinical, Inc.

Garden Grove, California, 92683, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Grossmont Center For Clinical Research

La Mesa, California, 92008, United States

Location

Clinical Trials Research

Sacramento, California, 91942, United States

Location

Research and Education Inc

San Diego, California, 92105, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Shahram Jacobs MD Inc

Sherman Oaks, California, 91403, United States

Location

Millennium ClinicalTrials

Thousand Oaks, California, 92840, United States

Location

Advanced Rx Clinical Research

Westminster, California, 91360, United States

Location

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

Location

PAB Clinical Research-ClinEdge-PPDS

Brandon, Florida, 33511, United States

Location

Nature Coast Clinical Research LLC - ERN-PPDS

Inverness, Florida, 34452, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Health Awareness Inc

Jupiter, Florida, 33458, United States

Location

Suncoast Research Group LLC - ERN-PPDS

Miami, Florida, 33135, United States

Location

Ormond Medical Arts Pharmaceutical

Ormond Beach, Florida, 32174, United States

Location

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Northwest Clinical Trials-ClinEdge-PPDS

Boise, Idaho, 83704, United States

Location

Synexus Clinical Research US, Inc. - Allaw

Evansville, Indiana, 47714, United States

Location

Boston Clinical Trials Inc

Boston, Massachusetts, 02131, United States

Location

West Michigan Clinical Research

Wyoming, Michigan, 49519, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Quality Clinical Research - ClinEdge - PPDS

Omaha, Nebraska, 68114, United States

Location

Albuquerque Clinical Trials Inc - BTC - PPDS

Albuquerque, New Mexico, 87102, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27262, United States

Location

PMG Research of Raleigh, LLC

Raleigh, North Carolina, 27609, United States

Location

Synexus Clinical Research US, Inc.

Akron, Ohio, 44311, United States

Location

Hometown Urgent Care and Research

Cincinnati, Ohio, 45215, United States

Location

Synexus Clinical Research US, Inc.

Columbus, Ohio, 45424, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 43212, United States

Location

Founders Research Corporation

Philadelphia, Pennsylvania, 19114, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Safe Harbor Clinical Research

East Providence, Rhode Island, 02914, United States

Location

Synexus Clinical Research US, Inc.

Anderson, South Carolina, 29621, United States

Location

Pledmont Research Partners LLC

Fort Mill, South Carolina, 29707, United States

Location

Synexus Clinical Research US, Inc.

Greer, South Carolina, 29651, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37909, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37421, United States

Location

L12 Clinical Research

Dallas, Texas, 75219, United States

Location

Synexus Clinical Research US, Inc.

Dallas, Texas, 78209, United States

Location

Southwest Clinical Trials

Houston, Texas, 77074, United States

Location

Quality Research Inc.

San Antonio, Texas, 75234, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Craig Basson
• Organization: Boston Pharmaceuticals, Inc.

clinicaltrials@bostonpharmaceuticals.com

(617) 655-9681

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: June 4, 2019
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (58)