Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
- Conditions
- Diarrhea-predominant Irritable Bowel Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT03977155
- Lead Sponsor
- Boston Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
-
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.
-
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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose of BOS-589 BOS-589 Participants will receive a low dose of BOS-589 orally BID. Placebo Placebo Participants will receive matching placebo orally BID. High dose of BOS-589 BOS-589 Participants will receive a high dose of BOS-589 orally twice a day (BID).
- Primary Outcome Measures
Name Time Method 24-hour Worst Abdominal Pain Scores (WAP) at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point) Baseline; Day 29 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.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Because of AEs, and Any Treatment-related Severe AEs Up to Day 43/end-of-study follow up visit To evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo.
- Secondary Outcome Measures
Name Time Method 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 To evaluate the treatment effect of BOS-589 on defecation after 4 weeks, relative to placebo. Participants were asked to record daily stool consistency according to the BSFS most representative of the past 24 hours. The participant-reported BSFS consistency score was based on a 1 to 7 scale where 1 corresponded to a hard stool and 7 corresponded to watery diarrhea. Higher scores indicated worse outcome.
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 To evaluate the treatment effect of BOS-589 on IBS related signs and symptoms. Participants were asked to record daily their overall diarrhea-predominant Irritable Bowel Syndrome (IBS-D) global symptoms in the prior 24 hours. The participant-reported daily IBS-GS was based on a 0 to 4 scale where: 0 corresponded to no symptoms; 1 corresponded to mild symptoms; 2 corresponded to moderate symptoms; 3 corresponded to severe symptoms; and 4 corresponded to very severe symptoms. Higher scores indicated severe symptoms.
AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) for BOS-589 Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose To evaluate the steady state PK of BOS-589.
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 To evaluate the treatment effect of BOS-589 on defecation after 4 weeks, relative to placebo. Participants were asked to record stool frequency based on the total number of spontaneous bowel movements in the past 24 hours.
Changes in the Irritable Bowel Syndrome-Severity Score (IBS-SS) at Day 29 Compared to Baseline Baseline; Day 29 To evaluate the treatment effect of BOS-589 on IBS-related signs and symptoms. Participants were asked to complete 5 questions regarding the severity of their IBS. Each of the 5 questions generated a maximum score of 100, leading to a total possible IBS-SS of 500. The IBS-SS scale ranges from 0 to 500. A higher score indicated greater severity.
Time to Reach Cmax (Tmax) for BOS-589 Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose To evaluate the steady state PK of BOS-589.
Area Under the Concentration-versus-time Curve (AUC) From Time Zero to 4 Hours Post Dose (AUC0-4) for BOS-589 Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose To evaluate the steady state PK of BOS-589.
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 To evaluate the treatment effect of BOS-589 on defecation after 4 weeks, relative to placebo. Participants were asked to record daily stool consistency according to the BSFS worst stool consistency (defined as the loosest stool with the highest BSFS score) in the past 24 hours. The participant-reported BSFS consistency score was based on a 1 to 7 scale where 1 corresponded to a hard stool and 7 corresponded to watery diarrhea. Higher scores indicated worse outcome.
Maximum Observed Plasma Concentration (Cmax) for BOS-589 Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose To evaluate the steady state pharmacokinetics (PK) of BOS-589.
Trial Locations
- Locations (51)
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Synexus Clinical Research US, Inc. - Phoenix Southeast
🇺🇸Chandler, Arizona, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, 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
Shahram Jacobs MD Inc
🇺🇸Sherman Oaks, California, United States
NY Scientific
🇺🇸Brooklyn, New York, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
Millennium ClinicalTrials
🇺🇸Thousand Oaks, California, United States
L12 Clinical Research
🇺🇸Dallas, Texas, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Chase Medical Research LLC
🇺🇸Waterbury, Connecticut, United States
PAB Clinical Research-ClinEdge-PPDS
🇺🇸Brandon, Florida, United States
Ormond Medical Arts Pharmaceutical
🇺🇸Ormond Beach, Florida, United States
Advanced Rx Clinical Research
🇺🇸Westminster, California, United States
Founders Research Corporation
🇺🇸Philadelphia, Pennsylvania, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
Albuquerque Clinical Trials Inc - BTC - PPDS
🇺🇸Albuquerque, New Mexico, United States
Nature Coast Clinical Research LLC - ERN-PPDS
🇺🇸Inverness, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
West Michigan Clinical Research
🇺🇸Wyoming, Michigan, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Synexus Clinical Research US, Inc.
🇺🇸Dallas, Texas, United States
Health Awareness Inc
🇺🇸Jupiter, Florida, United States
Synexus Clinical Research US, Inc. - Allaw
🇺🇸Evansville, Indiana, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
Pledmont Research Partners LLC
🇺🇸Fort Mill, South Carolina, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
Suncoast Research Group LLC - ERN-PPDS
🇺🇸Miami, Florida, United States
Research and Education Inc
🇺🇸San Diego, California, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Hope Research Institute LLC
🇺🇸Phoenix, Arizona, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
Clinical Research Partners LLC
🇺🇸Richmond, Virginia, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Quality Clinical Research - ClinEdge - PPDS
🇺🇸Omaha, Nebraska, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Synexus Clinical Research US, Inc. - Tatum Highlands Medical Associates, PLLC
🇺🇸Phoenix, 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
Northwest Clinical Trials-ClinEdge-PPDS
🇺🇸Boise, Idaho, United States