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

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ClinicalTrials.gov Identifier: NCT03977155
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diarrhea-predominant Irritable Bowel Syndrome Drug: BOS-589 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: High dose of BOS-589
Participants will receive a high dose of BOS-589 orally twice a day (BID).
Drug: BOS-589
oral tablets

Experimental: Low dose of BOS-589
Participants will receive a low dose of BOS-589 orally BID.
Drug: BOS-589
oral tablets

Placebo Comparator: Placebo
Participants will receive matching placebo orally BID.
Drug: Placebo
oral tablets




Primary Outcome Measures :
  1. 24-hour worst abdominal pain scores (WAP) at Day 29 compared to baseline (averaged over the week prior to each respective time point) [ Time Frame: Baseline; Day 29 ]
  2. Number of participants with any adverse event and any serious adverse event [ Time Frame: up to 10 weeks ]
  3. Number of participants who discontinued the study because of an adverse event [ Time Frame: up to 10 weeks ]
  4. Number of participants with any treatment-related severe adverse event [ Time Frame: up to 10 weeks ]

Secondary Outcome Measures :
  1. Change in stool consistency, measured by the daily Bristol Stool Form Score (BSFS) at Day 29 compared to baseline (averaged over the week prior to each respective time point) [ Time Frame: Baseline; Day 29 ]
  2. 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) [ Time Frame: Baseline; Day 29 ]
  3. Change in the Irritable Bowel Syndrome Severity Score (IBS-SS) at Day 29 compared to baseline [ Time Frame: Baseline; Day 29 ]
  4. Change in the IBS Global Scale (IBS-GS) at Day 29 compared to baseline (averaged over the week prior to each respective time point) [ Time Frame: Baseline; Day 29 ]
  5. Maximum observed plasma concentration (Cmax) [ Time Frame: predose and 0.5, 1, 2, and 4 hours postdose on Days 1 and 15 (samples should be collected on Day 22 if they cannot be collected on Day 15); predose on Days 8, 22, and 29 ]
  6. Time to Cmax (Tmax) [ Time Frame: predose and 0.5, 1, 2, and 4 hours postdose on Days 1 and 15 (samples should be collected on Day 22 if they cannot be collected on Day 15); predose on Days 8, 22, and 29 ]
  7. Minimum plasma concentration (Cmin) [ Time Frame: predose and 0.5, 1, 2, and 4 hours postdose on Days 1 and 15 (samples should be collected on Day 22 if they cannot be collected on Day 15); predose on Days 8, 22, and 29 ]
  8. Area under the concentration versus time curve (AUC) from time zero to 4 hours post dose (AUC0-4) [ Time Frame: predose and 0.5, 1, 2, and 4 hours postdose on Days 1 and 15 (samples should be collected on Day 22 if they cannot be collected on Day 15); predose on Days 8, 22, and 29 ]
  9. AUC from time zero to the last quantifiable concentration (AUC0-t) [ Time Frame: predose and 0.5, 1, 2, and 4 hours postdose on Days 1 and 15 (samples should be collected on Day 22 if they cannot be collected on Day 15); predose on Days 8, 22, and 29 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977155


Contacts
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Contact: Philip Yin 617-826-0300 phil@bostonpharmaceuticals.com
Contact: Peter Ho 617-826-0300 peter@bostonpharmaceuticals.com

  Show 33 Study Locations
Sponsors and Collaborators
Boston Pharmaceuticals

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Responsible Party: Boston Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03977155     History of Changes
Other Study ID Numbers: BOS-589-201
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Pharmaceuticals:
Irritable Bowel Sydrome
diarrhea
BOS-589

Additional relevant MeSH terms:
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Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases