Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Urovant Sciences GmbH
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
Clareo Health | Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
