Irritable Bowel Syndrome With Diarrhea (IBS-D)Phase 2NCT03931785

A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

A Phase 2 study testing MD-7246 in people with Irritable Bowel Syndrome With Diarrhea (IBS-D), run by Ironwood Pharmaceuticals, Inc. at 80 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

To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome With Diarrhea (IBS-D)
What is being tested?: MD-7246
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 515 participants
Where: 80 sitesUnited States
Study dates: 1 May 2019to 11 Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient meets the Rome IV criteria for diagnosis of IBS-D
Patient maintains a minimum level of compliance with daily diary
Female patients of childbearing potential must agree to use one of the following methods of birth control:
Hormonal contraception
Double-barrier method
Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy

Who cannot join

Patient has clinically significant findings on a physical examination and/or clinical laboratory tests
Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
NOTE: Additional inclusion/exclusion criteria may apply

Trial locations and contacts

80 sites in 1 country.

City, postcode or hospital

80 sites in 1 country

United States80 sites

MW Clinical Research Center
Beaumont, Texas, 77701
Boston Clinical Trials Inc
Boston, Massachusetts, 02131
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59718
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010
Healthwise Medical Associates
Brooklyn, New York, 11206
Carolina Digestive Health Associates
Charlotte, North Carolina, 28210
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Galen Research
Chesterfield, Missouri, 63005
New River Valley Research Institute
Christiansburg, Virginia, 24073
GW Research, Inc.
Chula Vista, California, 91910
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215
Hightop Medical Research Center
Cincinnati, Ohio, 45224
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Hometown Urgent Care and Research
Columbus, Ohio, 42314
Remington Davis Inc
Columbus, Ohio, 43215
Carolina Digestive Health Associates
Concord, North Carolina, 28025
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879
Partners In Clinical Research
Cumberland, Rhode Island, 02864
Hometown Urgent Care and Research
Dayton, Ohio, 45424
Texas Tech University Health Sciences Center
El Paso, Texas, 79905-2709
Diagnamics Inc.
Encinitas, California, 92024
New England Center For Clinical Research Inc PrimaCare Research, LLC
Fall River, Massachusetts, 02721
Lillestol Research
Fargo, North Dakota, 58104
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Paragon Rx Clinical
Garden Grove, California, 92840
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, 11023
Mountain View Clinical Research Inc
Greer, South Carolina, 29651
Meritus Center For Clinical Research
Hagerstown, Maryland, 21742
Chase Medical Research of Greater New Haven LLC
Hamden, Connecticut, 06517
Peters Medical Research, LLC
High Point, North Carolina, 27262
Southwest Clinical Trials
Houston, Texas, 77074
Southwest Clinical Trials
Houston, Texas, 77081
Clinical Research Associates
Huntsville, Alabama, 35801
The Chappel Group Research, LLC
Kissimmee, Florida, 34744
New Phase Research & Development
Knoxville, Tennessee, 37909
Grossmont Center For Clinical Research
La Mesa, California, 91942
Barrett Clinic, P.C. - BTC - PPDS
La Vista, Nebraska, 68128
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865
Clinical Trials Management LLC
Metairie, Louisiana, 70006
Well Pharma Medical Research Corporation
Miami, Florida, 33143
New Horizon Research Center
Miami, Florida, 33175
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014
Facey Medical Foundation
Mission Hills, California, 91345
Clinical Trials of America-NC, LLC
Mount Airy, North Carolina, 27030
Central Sooner Research
Norman, Oklahoma, 73071
Providence Clinical Research
North Hollywood, California, 91606
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Advanced Research Institute
Ogden, Utah, 84405
IPS Research Company
Oklahoma City, Oklahoma, 73106
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112
Meridian Clinical Research
Omaha, Nebraska, 68134
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Elite Clinical Studies
Phoenix, Arizona, 85018
M3 Wake Research, Inc
Raleigh, North Carolina, 43212
Rochester Clinical Research, Inc
Rochester, New York, 14609
Rockford Gastroenterology Associates LTD
Rockford, Illinois, 61107
Meridian Clinical Research
Rockville, Maryland, 20854
Oregon Center For Clinical Investigations Inc
Salem, Oregon, 97301
Quality Research Inc
San Antonio, Texas, 78209
Diagnostics Research Group
San Antonio, Texas, 78229
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258
Precision Research Institute
San Diego, California, 92114
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, 92703
UNISON Clinical Trials
Sherman Oaks, California, 91403
Meridien Research
St. Petersburg, Florida, 33709
Millennium Clinical Trials
Thousand Oaks, California, 91360
MedVadis Research Corporation
Watertown, Massachusetts, 02472
Clinical Trials of America -- LA LLC
West Monroe, Louisiana, 71291
Palm Beach Research Center
West Palm Beach, Florida, 33409
Advanced Rx Clinical Research
Westminster, California, 92683
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
Research Institute of Central Florida, LLC
Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
Being tested: MD-7246, Placebo
Keywords: Abdominal pain, Diarrhea, Irritable Bowel Syndrome
Medical subject headings: Abdominal Pain, Diarrhea, Irritable Bowel Syndrome

What participants receive

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

MD-7246Drug
Oral tablet
PlaceboDrug
Matching oral tablet

Study groups in NCT03931785
Study group	Role	What they receive
MD-7246 300 μg	Experimental	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets Receives: Drug: MD-7246; Drug: Placebo
MD-7246 600 μg	Experimental	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets Receives: Drug: MD-7246; Drug: Placebo
MD-7246 1200 μg	Experimental	4 MD-7246 300-μg oral tablets Receives: Drug: MD-7246
Placebo	Placebo comparator	4 matching placebo oral tablets Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score.
Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect.
Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.
Measured: Baseline, up to Week 12 (end of the Treatment Period)
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week.
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.
Measured: Baseline through Week 12

Timeline

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

1 May 201911 Mar 2020

First posted30 Apr 2019
Study start1 May 2019
Primary completion26 Feb 2020
Study completion11 Mar 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 Irritable Bowel Syndrome With Diarrhea (IBS-D)Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 515 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03931785
Sponsor's protocol ID: MCP-103-205
Status last verified: Feb 2021
First submitted: 22 Apr 2019
Last updated: 12 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: 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

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Recruiting
Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
Irritable Bowel Syndrome With Diarrhea

All Irritable Bowel Syndrome With Diarrhea (IBS-D) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT03931785
Acronym / sponsor ID: MCP-103-205
Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
Keywords: Abdominal pain, Diarrhea, Irritable Bowel Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 515 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Allergan Sales, LLC
Study start: 1 May 2019 (actual)
Primary completion: 26 Feb 2020 (actual)
Study completion: 11 Mar 2020 (actual)
First posted: 30 Apr 2019 (actual)
Results: Posted 12 Mar 2021

Clinical summary

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

To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MD-7246 300 μg	Experimental	Drug: MD-7246, Drug: Placebo1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
MD-7246 600 μg	Experimental	Drug: MD-7246, Drug: Placebo2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
MD-7246 1200 μg	Experimental	Drug: MD-72464 MD-7246 300-μg oral tablets
Placebo	Placebo comparator	Drug: Placebo4 matching placebo oral tablets

Who may qualify

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

Key inclusion criteria (6 listed)

Patient meets the Rome IV criteria for diagnosis of IBS-D
Patient maintains a minimum level of compliance with daily diary
Female patients of childbearing potential must agree to use one of the following methods of birth control:

Key exclusion criteria (5 listed)

Patient has clinically significant findings on a physical examination and/or clinical laboratory tests
Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
NOTE: Additional inclusion/exclusion criteria may apply

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
MD-7246Oral tablet	Drug	MD-7246 1200 μg, MD-7246 300 μg, MD-7246 600 μg
PlaceboMatching oral tablet	Drug	MD-7246 300 μg, MD-7246 600 μg, Placebo

Primary outcome

Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
Time frame: Baseline, up to Week 12 (end of the Treatment Period)
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
Time frame: Baseline through Week 12
A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.

Results and safety

Results posted to the registry on 12 Mar 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
Placebo	97	92
MD-7246 300 μg	97	90
MD-7246 600 μg	97	84
MD-7246 1200 μg	97	86

Primary outcome: Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period

Time frame: Baseline, up to Week 12 (end of the Treatment Period). Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 97	MD-7246 300 μg n = 97	MD-7246 600 μg n = 97	MD-7246 1200 μg n = 97
Value	-2.01 (0.179)	-1.93 (0.179)	-1.58 (0.182)	-1.95 (0.180)

Placebo vs MD-7246 300 μg: Least squares (LS) mean difference: 0.08 (95% CI -0.42 to 0.58), p = 0.7467, MMRM
Placebo vs MD-7246 600 μg: LS mean difference: 0.43 (95% CI -0.07 to 0.93), p = 0.0941, MMRM
Placebo vs MD-7246 1200 μg: LS mean difference: 0.06 (95% CI -0.44 to 0.56), p = 0.8098, MMRM

Population analysed: Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at Baseline and during the treatment period.

Primary outcome: Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders

Time frame: Baseline through Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 97	MD-7246 300 μg n = 97	MD-7246 600 μg n = 97	MD-7246 1200 μg n = 97
Value	55.7	56.7	44.3	48.5

Placebo vs MD-7246 300 μg: Difference in Responder Rate: 1.0 (95% CI -12.9 to 15.0)
Placebo vs MD-7246 600 μg: Difference in Responder Rate: -11.3 (95% CI -25.3 to 2.6)
Placebo vs MD-7246 1200 μg: Difference in Responder Rate: -7.2 (95% CI -21.2 to 6.8)

Adverse events

Time frame: From the first dose of double-blind study drug and within 1 day of the date of last dose of double-blind study drug in the treatment period (up to Week 12 / Day 85). Mean treatment duration was 82.8, 77.3, and 80.8 days in the MD-7246 300, 600, and 1200 μg groups, respectively, and 83.3 days in the placebo group.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 97 (0%)	27 of 97 (27.8%)	0 of 97
MD-7246 300 μg	0 of 97 (0%)	28 of 97 (28.9%)	0 of 97
MD-7246 600 μg	0 of 97 (0%)	42 of 97 (43.3%)	0 of 97
MD-7246 1200 μg	1 of 97 (1%)	52 of 97 (53.6%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Irritable Bowel Syndrome With Diarrhea (IBS-D)

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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Recruiting
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Irritable Bowel Syndrome With Diarrhea

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.

Wilmin Bartolini, PhD study chair

Ironwood Pharmaceuticals, Inc.

80 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 MD-7246 in people with Irritable Bowel Syndrome With Diarrhea (IBS-D), run by Ironwood Pharmaceuticals, Inc. at 80 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 6 inclusion and 5 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 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 12 Mar 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?

Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period (time frame: Baseline, up to Week 12 (end of the Treatment Period)). 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 NCT03931785.

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 12 Mar 2021.