Trial · NCT03806127
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
NCT03806127, Phase 2, Completed, Urovant Sciences GmbH; results first posted 2021-07-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome. Trials, record NCT03806127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03806127
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
- NCT number
- NCT03806127
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 222 participants, actual
- Lead sponsor
- Urovant Sciences GmbH
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Vibegron, Placebo
- First posted
- 2019-01-16
- Last updated
- 2021-08-02
- Results first posted
- 2021-07-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | 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). |
| Secondary | Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Week 12 | 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. |
| Secondary | Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | Baseline; 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). |
| Secondary | Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks | Baseline; 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). |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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) | 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. |
| Secondary | Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12 | Baseline; Week 12 | The investigator determined whether a change was clinically meaningful. |
| Secondary | Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12 | Baseline; Week 12 | Clinical relevance was determined by the investigator. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | Baseline; Week 12 | 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Week 12 | Full Analysis Set: all randomized participants 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | Baseline; 12 weeks | Full Analysis Set for IBS-D participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks | Baseline; 12 weeks | Full Analysis Set for IBS-D participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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) | Safety Analysis Set: all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12 | Baseline; Week 12 | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12 | Baseline; Week 12 | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | Placebo | 27 | Participants | ||
| Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | Vibegron 75 mg | 27 | Participants | ||
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Placebo | IBS-D Participants | 21 | Participants | |
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Vibegron 75 mg | IBS-D Participants | 28 | Participants | |
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Placebo | IBS-M Participants | 16 | Participants | |
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Vibegron 75 mg | IBS-M Participants | 16 | Participants | |
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Placebo | All Participants | 37 | Participants | |
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Vibegron 75 mg | All Participants | 44 | Participants | |
| Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | Placebo | 20 | Participants | ||
| Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | Vibegron 75 mg | 22 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 111 | |
| Overall Study | STARTED | Vibegron 75 mg | 111 | |
| Overall Study | COMPLETED | Placebo | 90 | |
| Overall Study | COMPLETED | Vibegron 75 mg | 99 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Vibegron 75 mg | 12 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 111 | |
| other | Constipation | Gastrointestinal disorders | Vibegron 75 mg | 1 | 111 | |
| other | Irritable bowel syndrome | Gastrointestinal disorders | Placebo | 3 | 111 | |
| other | Irritable bowel syndrome | Gastrointestinal disorders | Vibegron 75 mg | 3 | 111 | |
| other | Bacteriuria | Infections and infestations | Placebo | 5 | 111 | |
| other | Bacteriuria | Infections and infestations | Vibegron 75 mg | 3 | 111 | |
| other | Gastroenteritis | Infections and infestations | Placebo | 0 | 111 | |
| other | Gastroenteritis | Infections and infestations | Vibegron 75 mg | 3 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Vibegron 75 mg | 0 | 111 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 111 |
| Total, all-cause mortality | Vibegron 75 mg | 0 | 111 |
| Total, other adverse events | Placebo | 19 | 111 |
| Total, other adverse events | Vibegron 75 mg | 13 | 111 |
| Total, serious adverse events | Placebo | 1 | 111 |
| Total, serious adverse events | Vibegron 75 mg | 2 | 111 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vibegron 75 mg vs Placebo: Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | Trial comparisons |
| Vibegron 75 mg vs Placebo: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Vibegron 75 mg vs Placebo: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | Trial comparisons |
| Vibegron 75 mg vs Placebo: Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12 | Trial comparisons |
| Vibegron 75 mg vs Placebo: Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12 | Trial comparisons |
| Vibegron 75 mg vs Placebo: deaths from any cause | Trial comparisons |
| Vibegron 75 mg vs Placebo: Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks | Trial comparisons |
| Vibegron 75 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03806127
GET https://conductscience.org/api/trials/v1/NCT03806127/events?page=2