Status:
UNKNOWN
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
Lead Sponsor:
Seoul National University Hospital
Conditions:
Fecal Incontinence
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief Summary
This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are: 1....
Eligibility Criteria
Inclusion
- Patients diagnosed with fecal incontinence (patients with 2 or more symptoms of fecal incontinence per month for at least 3 months).
- Patients who are able to understand and comply with this study.
- Individuals who are agreeable to being on contraception for the duration of the study.
Exclusion
- Patients who have difficulty swallowing medications
- Patients with gastrointestinal deformities due to surgery
- Patients with malabsorption
- Patients with inflammatory bowel disease (IBD)
- Patients undergoing treatment for cancer of the gastrointestinal tract
- Patients who are allergic to the study drug
- Patients with overflow incontinence and fecal impaction on rectal residual examination (DRE) or Bristol Stool Scale of 3 or less.
- Patients taking medication for fecal incontinence within 1 month of study entry.
- Pregnant or lactating women.
- Patients with contraindications to any of the study drugs (i.e., intestinal obstruction, intestinal stones, acute abdomen, undiagnosed abdominal pain/nausea/vomiting, gastrointestinal stenosis and dysphagia, patients with megacolon syndrome, severe diabetes, etc.).
- Patients taking an agent that is contraindicated in combination with either study drug.
- Patients deemed by the investigator and staff to be unsuitable for participation in the study.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06166615
Start Date
December 15 2023
End Date
November 1 2024
Last Update
December 12 2023
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