The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence

Last updated: December 3, 2023
Sponsor: Seoul National University Hospital
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Bowel Dysfunction

Fecal Incontinence

Rectal Disorders

Treatment

Psyllium

Ramosetron

Clinical Study ID

NCT06166615
H-2303-158-1417
  • Ages > 19
  • All Genders

Study 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. Does Ramosetron improve the symptoms of fecal incontinence?

  2. Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life?

Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients diagnosed with fecal incontinence (patients with 2 or more symptoms of fecalincontinence per month for at least 3 months).
  2. Patients who are able to understand and comply with this study.
  3. Individuals who are agreeable to being on contraception for the duration of the study.

Exclusion

Exclusion Criteria:

  1. Patients who have difficulty swallowing medications
  2. Patients with gastrointestinal deformities due to surgery
  3. Patients with malabsorption
  4. Patients with inflammatory bowel disease (IBD)
  5. Patients undergoing treatment for cancer of the gastrointestinal tract
  6. Patients who are allergic to the study drug
  7. Patients with overflow incontinence and fecal impaction on rectal residual examination (DRE) or Bristol Stool Scale of 3 or less.
  8. Patients taking medication for fecal incontinence within 1 month of study entry.
  9. Pregnant or lactating women.
  10. Patients with contraindications to any of the study drugs (i.e., intestinalobstruction, intestinal stones, acute abdomen, undiagnosed abdominalpain/nausea/vomiting, gastrointestinal stenosis and dysphagia, patients with megacolonsyndrome, severe diabetes, etc.).
  11. Patients taking an agent that is contraindicated in combination with either studydrug.
  12. Patients deemed by the investigator and staff to be unsuitable for participation inthe study.

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Psyllium
Phase: 2/3
Study Start date:
December 15, 2023
Estimated Completion Date:
November 01, 2024