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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
222
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).
Time frame: Baseline; Week 12
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.
Time frame: 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).
Time frame: 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).
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Synexus Clinical Research US, Inc.-Simon Williamson Clinic
Birmingham, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Alabama Medical Group, PC
Mobile, Alabama, United States
Hope Research Institute
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, United States
Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
Phoenix, Arizona, United States
GW Research Inc - ClinEdge-PPDS
Chula Vista, California, United States
Triwest Research Associates, LLC
La Mesa, California, United States
...and 31 more locations
Time frame: 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.
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
The investigator determined whether a change was clinically meaningful.
Time frame: 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.
Time frame: Baseline; Week 12