Irritable Bowel SyndromePhase 2NCT03806127

Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

A Phase 2 study testing Vibegron in people with Irritable Bowel Syndrome, run by Urovant Sciences GmbH at 41 sites in United States.

Completed

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

Official record

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Trial summary

This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M). Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: Vibegron
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 222 participants
Where: 41 sitesUnited States
Study dates: 31 Dec 2018to 6 Oct 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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

Who cannot join

Diagnosis of IBS-C or IBS-U per Rome IV criteria
History of chronic idiopathic constipation or functional constipation
Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease
Planned gastrointestinal or abdominal surgery within the next 6 months
Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms
Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, 29621
University of Michigan
Ann Arbor, Michigan, 48109
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440
Synexus Clinical Research US, Inc.-Simon Williamson Clinic
Birmingham, Alabama, 35211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hope Research Institute
Chandler, Arizona, 85224
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, 85224
Atrium Healthcare Center for Digestive Health
Charlotte, North Carolina, 28204
Chattanooga Medical Research Inc
Chattanooga, Tennessee, 37404
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
GW Research Inc - ClinEdge-PPDS
Chula Vista, California, 91910
DHAT Research Institute
Garland, Texas, 75044
Carolina Digestive Diseases
Greenville, North Carolina, 27834
Medical Research Center of Connecticut LLC
Hamden, Connecticut, 06518
Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
Henderson, Nevada, 89502
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Clinical Research Associates
Huntsville, Alabama, 35801
Investigators Research Group, LLC
Indianapolis, Indiana, 46268
Clinical Research Solutions PC
Jackson, Tennessee, 38305
Mayo Clinic - Division of Gastroenterology
Jacksonville, Florida, 32224
East Carolina Gastroenterology
Jacksonville, North Carolina, 28546
Triwest Research Associates, LLC
La Mesa, California, 91942
Florida Center For Gastroenterology
Largo, Florida, 33777
Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
Layton, Utah, 84041
VA Long Beach Healthcare System - NAVREF
Long Beach, California, 90822
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, 90045
Mandeville Private Physician Group, LLC
Mandeville, Louisiana, 70471
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, 85206
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, 85213
Alabama Medical Group, PC
Mobile, Alabama, 36693
Central Sooner Research
Norman, Oklahoma, 73071
Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
Phoenix, Arizona, 85020
Synexus Clinical Research US, Inc.-Plano
Plano, Texas, 75093
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Advanced Research Institute
Reno, Nevada, 89511
Desta Digestive Disease Medical Center
San Diego, California, 92114
Medical Associates Research Group, Inc.
San Diego, California, 92123
Advanced Research Institute
South Ogden, Utah, 84405
RNA America, LLC
Sugar Hill, Georgia, 30518
Torrance Clinical Research
Torrance, California, 90505
Palm Beach Research - ClinEdge - PPDS
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

Conditions: Irritable Bowel Syndrome
Being tested: Vibegron, Placebo
Keywords: Irritable Bowel Syndrome, Irritable Bowel Syndrome with predominantly diarrhea (IBS-D), Irritable Bowel Syndrome with mixed episodes of diarrhea and constipation (IBS-M), Vibegron, Beta-3 adrenergic receptor (β3-AR), Pain
Medical subject headings: Irritable Bowel Syndrome, Constipation, Pain

What participants receive

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

VibegronDrug
Also called RVT-901, MK-4618, KRP-114V, URO-901
oral administration
PlaceboDrug
oral administration

Study groups in NCT03806127
Study group	Role	What they receive
Vibegron 75 mg	Experimental	Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks. Receives: Drug: Vibegron
Placebo	Placebo comparator	Participants will receive matching placebo orally once daily for 12 weeks. Receives: Drug: Placebo

What is being measured

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

Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Measured: Baseline; Week 12

Secondary outcomes (6)

Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.
Measured: Week 12
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Measured: Baseline; 12 weeks
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Measured: Baseline; 12 weeks
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.
Measured: from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
The investigator determined whether a change was clinically meaningful.
Measured: Baseline; Week 12
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
Clinical relevance was determined by the investigator.
Measured: Baseline; Week 12

Timeline

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

31 Dec 20186 Oct 2020

First posted16 Jan 2019
Study start31 Dec 2018
Primary completion25 Sep 2020
Study completion6 Oct 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 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: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03806127
Sponsor's protocol ID: URO-901-2001
Status last verified: Jul 2021
First submitted: 14 Jan 2019
Last updated: 2 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT03806127
Acronym / sponsor ID: URO-901-2001
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome, Irritable Bowel Syndrome with predominantly diarrhea (IBS-D), Irritable Bowel Syndrome with mixed episodes of diarrhea and constipation (IBS-M), Vibegron, Beta-3 adrenergic receptor (β3-AR), Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: Urovant Sciences GmbHIndustry (pharma, biotech, devices)
Study start: 31 Dec 2018 (actual)
Primary completion: 25 Sep 2020 (actual)
Study completion: 6 Oct 2020 (actual)
First posted: 16 Jan 2019 (actual)
Results: Posted 30 Jul 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: 2

Arm	Type	Receives
Vibegron 75 mg	Experimental	Drug: VibegronParticipants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive matching placebo orally once daily for 12 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

Key exclusion criteria (8 listed)

Diagnosis of IBS-C or IBS-U per Rome IV criteria
History of chronic idiopathic constipation or functional constipation
Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease

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
VibegronAlso: RVT-901, MK-4618, KRP-114V, URO-901oral administration	Drug	Vibegron 75 mg
Placebooral administration	Drug	Placebo

Primary outcome

Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
Time frame: Baseline; Week 12
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).

6 secondary outcomes

Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
Time frame: Week 12
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
Time frame: Baseline; 12 weeks
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
Time frame: Baseline; 12 weeks
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
Time frame: Baseline; Week 12
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
Time frame: Baseline; Week 12

Results and safety

Results posted to the registry on 30 Jul 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	111	90
Vibegron 75 mg	111	99

Primary outcome: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12

Time frame: Baseline; Week 12. Count of participants. Unit: Participants

Measure	Placebo n = 63	Vibegron 75 mg n = 66
Value	27	27

Placebo vs Vibegron 75 mg: Cochran-Mantel-Haenszel (CMH) Difference: -1.9 (90% CI -16.1 to 12.3)

Population analysed: Full Analysis Set for IBS-D participants: all randomized participants with IBS-D who who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 111 (0.9%)	19 of 111 (17.1%)	0 of 111
Vibegron 75 mg	2 of 111 (1.8%)	13 of 111 (11.7%)	0 of 111

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Irritable Bowel Syndrome

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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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.

41 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 Vibegron in people with Irritable Bowel Syndrome, run by Urovant Sciences GmbH at 41 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 3 inclusion and 8 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 30 Jul 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?

Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 (time frame: Baseline; Week 12). 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 NCT03806127.

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 2 Aug 2021.