Diarrhea-predominant Irritable Bowel SyndromePhase 2NCT03977155

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

A Phase 2 study testing BOS-589 in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Boston Pharmaceuticals at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diarrhea-predominant Irritable Bowel Syndrome
What is being tested?: BOS-589
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 58 sitesUnited States
Study dates: 4 Jun 2019to 6 May 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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.)

Trial locations and contacts

58 sites in 1 country.

City, postcode or hospital

58 sites in 1 country

United States58 sites

Synexus Clinical Research US, Inc.
Akron, Ohio, 44311
Albuquerque Clinical Trials Inc - BTC - PPDS
Albuquerque, New Mexico, 87102
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621
Pinnacle Research Group
Anniston, Alabama, 36207
Northwest Clinical Trials-ClinEdge-PPDS
Boise, Idaho, 83704
Boston Clinical Trials Inc
Boston, Massachusetts, 02131
PAB Clinical Research-ClinEdge-PPDS
Brandon, Florida, 33511
NY Scientific
Brooklyn, New York, 11235
Synexus Clinical Research US, Inc.
Carlsbad, California, 95821
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, 85224
Synexus Clinical Research US, Inc. - Phoenix Southeast
Chandler, Arizona, 85224
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37909
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215
Synexus Clinical Research US, Inc.
Columbus, Ohio, 45424
L12 Clinical Research
Dallas, Texas, 75219
Synexus Clinical Research US, Inc.
Dallas, Texas, 78209
Hometown Urgent Care and Research
Dayton, Ohio, 43212
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Synexus Clinical Research US, Inc. - Allaw
Evansville, Indiana, 47714
Pledmont Research Partners LLC
Fort Mill, South Carolina, 29707
Paragon Rx Clinical, Inc.
Garden Grove, California, 92683
Synexus Clinical Research US, Inc.
Greer, South Carolina, 29651
Peters Medical Research, LLC
High Point, North Carolina, 27262
Southwest Clinical Trials
Houston, Texas, 77074
Clinical Research Associates
Huntsville, Alabama, 35801
Nature Coast Clinical Research LLC - ERN-PPDS
Inverness, Florida, 34452
Mayo Clinic
Jacksonville, Florida, 32224
Health Awareness Inc
Jupiter, Florida, 33458
New Phase Research & Development
Knoxville, Tennessee, 37421
eStudySite
La Mesa, California, 91942
Grossmont Center For Clinical Research
La Mesa, California, 92008
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, 85018
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, 85213
Suncoast Research Group LLC - ERN-PPDS
Miami, Florida, 33135
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Advanced Research Institute
Ogden, Utah, 84405
Quality Clinical Research - ClinEdge - PPDS
Omaha, Nebraska, 68114
Ormond Medical Arts Pharmaceutical
Ormond Beach, Florida, 32174
Hope Research Institute LLC
Peoria, Arizona, 85381
Founders Research Corporation
Philadelphia, Pennsylvania, 19114
Elite Clinical Studies
Phoenix, Arizona, 85018
Synexus Clinical Research US, Inc. - Tatum Highlands Medical Associates, PLLC
Phoenix, Arizona, 85050
Hope Research Institute LLC
Phoenix, Arizona, 85206
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Clinical Research Partners LLC
Richmond, Virginia, 23235
Clinical Trials Research
Sacramento, California, 91942
Quality Research Inc.
San Antonio, Texas, 75234
Research and Education Inc
San Diego, California, 92105
Precision Research Institute
San Diego, California, 92114
Shahram Jacobs MD Inc
Sherman Oaks, California, 91403
Sundance Clinical Research
St Louis, Missouri, 63141
Precision Clinical Research, LLC
Sunrise, Florida, 33351
Millennium ClinicalTrials
Thousand Oaks, California, 92840
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Chase Medical Research LLC
Waterbury, Connecticut, 06708
Advanced Rx Clinical Research
Westminster, California, 91360
West Michigan Clinical Research
Wyoming, Michigan, 49519

Other trials in United States

About this study

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)

Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Being tested: BOS-589, Placebo
Keywords: Irritable Bowel Syndrome, diarrhea, BOS-589
Medical subject headings: Irritable Bowel Syndrome, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOS-589Drug
oral tablets
PlaceboDrug
oral tablets

Study groups in NCT03977155
Study group	Role	What they receive
High dose of BOS-589	Experimental	Participants will receive a high dose of BOS-589 orally twice a day (BID). Receives: Drug: BOS-589
Low dose of BOS-589	Experimental	Participants will receive a low dose of BOS-589 orally BID. Receives: Drug: BOS-589
Placebo	Placebo comparator	Participants will receive matching placebo orally BID. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline; Day 29
Changes in the Irritable Bowel Syndrome-Severity Score (IBS-SS) at Day 29 Compared to Baseline
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.
Measured: 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)
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.
Measured: Baseline; Day 29
Maximum Observed Plasma Concentration (Cmax) for BOS-589
To evaluate the steady state pharmacokinetics (PK) of BOS-589.
Measured: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose
Time to Reach Cmax (Tmax) for BOS-589
To evaluate the steady state PK of BOS-589.
Measured: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose
Area Under the Concentration-versus-time Curve (AUC) From Time Zero to 4 Hours Post Dose (AUC0-4) for BOS-589
To evaluate the steady state PK of BOS-589.
Measured: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose
AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) for BOS-589
To evaluate the steady state PK of BOS-589.
Measured: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 20196 May 2020

First posted6 Jun 2019
Study start4 Jun 2019
Primary completion6 May 2020
Study completion6 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03977155
Sponsor's protocol ID: BOS-589-201
Status last verified: Jun 2021
First submitted: 5 Jun 2019
Last updated: 7 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diarrhea-predominant Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03977155
Acronym / sponsor ID: BOS-589-201
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome, diarrhea, BOS-589
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Boston PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 4 Jun 2019 (actual)
Primary completion: 6 May 2020 (actual)
Study completion: 6 May 2020 (actual)
First posted: 6 Jun 2019 (actual)
Results: Posted 7 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
High dose of BOS-589	Experimental	Drug: BOS-589Participants will receive a high dose of BOS-589 orally twice a day (BID).
Low dose of BOS-589	Experimental	Drug: BOS-589Participants will receive a low dose of BOS-589 orally BID.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive matching placebo orally BID.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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
Recurrent abdominal pain occurring, on average, at least 1 day per week and associated with 2 or more of the following:
Over the week prior to randomization, the participant has
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.

Key exclusion criteria (12 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BOS-589oral tablets	Drug	High dose of BOS-589, Low dose of BOS-589
Placebooral tablets	Drug	Placebo

Primary outcome

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
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
Time frame: 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.

9 secondary outcomes

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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline; Day 29
Changes in the Irritable Bowel Syndrome-Severity Score (IBS-SS) at Day 29 Compared to Baseline
Time frame: 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)
Time frame: Baseline; Day 29
Maximum Observed Plasma Concentration (Cmax) for BOS-589
Time frame: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose
Time to Reach Cmax (Tmax) for BOS-589
Time frame: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose
Area Under the Concentration-versus-time Curve (AUC) From Time Zero to 4 Hours Post Dose (AUC0-4) for BOS-589
Time frame: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose
AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) for BOS-589
Time frame: Day 1, Day 15 and Day 22 at pre-dose and at 0.5, 1, 2, and 4 hours post-dose

Results and safety

Results posted to the registry on 7 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose of BOS-589	43	38
Low Dose of BOS-589	48	46
Placebo	42	40

Primary outcome: 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. Mean (Standard Deviation). Unit: Score on a scale

Measure	High Dose of BOS-589 n = 39	Low Dose of BOS-589 n = 46	BOS-589: Active Treatment n = 85	Placebo n = 40
Value	-1.64 (1.684)	-2.30 (1.933)	-2.00 (1.842)	-1.69 (1.783)

BOS-589: Active Treatment vs Placebo: Mean Difference (Net): -0.31 (95% CI -1.00 to 0.38), p = 0.3776, t test
High Dose of BOS-589 vs Placebo: Mean Difference (Net): 0.04 (95% CI -0.73 to 0.82)
Low Dose of BOS-589 vs Placebo: Mean Difference (Net): -0.61 (95% CI -1.41 to 0.19)

Population analysed: The Intent to Treat (ITT) Analysis Set included all randomized participants. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

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

Time frame: Up to Day 43/end-of-study follow up visit. Number. Unit: Participants

Measure	High Dose of BOS-589 n = 43	Low Dose of BOS-589 n = 48	Placebo n = 42
Any Treatment-emergent adverse event (TEAE)	23	23	15
Any TEAE Related to Study Drug	8	5	4
Any Moderate or Severe TEAE	10	10	6
Any Moderate or Severe TEAE Related to Study Drug	3	3	1
Any Treatment-Emergent SAE	0	0	0
Any Treatment-Emergent SAE Related to Study Drug	0	0	0
Any TEAE Causing Discontinuation of Study Drug	3	0	0
Any TEAE Leading to Withdrawal from the Study	3	0	0

Population analysed: The Safety Analysis Set included all participants who received at least 1 dose of study drug.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 43/end-of-study follow up visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose of BOS-589	0 of 43 (0%)	23 of 43 (53.5%)	0 of 43
Low Dose of BOS-589	0 of 48 (0%)	23 of 48 (47.9%)	0 of 48
Placebo	0 of 42 (0%)	15 of 42 (35.7%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

58 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOS-589 in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Boston Pharmaceuticals at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03977155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.