Trial · NCT06166615
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
NCT06166615, Phase 2, Phase 3, Active not recruiting, Seoul National University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence. Trials, record NCT06166615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06166615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
- NCT number
- NCT06166615
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 147 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Fecal Incontinence
- Interventions
- Ramosetron, Psyllium
- First posted
- 2023-12-12
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in total Fecal Incontinence Severity Index (FISI) from baseline to 1 month | The FISI scores will be assessed at two time points - at baseline (prior to the initiation of treatment) and at 1 month post-treatment initiation. | Within each treatment arm, change in total Fecal Incontinence Severity Index (FISI) score from baseline to 1 month after treatment initiation. FISI is a patient-reported measure of the type and frequency of fecal incontinence. Total scores range from 0 to 61; higher scores indicate greater severity. A decrease from baseline indicates improvement. |
| Secondary | Difference in Fecal Incontinence Severity Index (FISI) Scores Between the Two Groups | Measured at baseline and 1-,4-, and 12-month. | Between-group comparison of the change in total Fecal Incontinence Severity Index (FISI) score from baseline in the ramosetron and psyllium groups. FISI scores range from 0 to 61; higher scores indicate greater fecal incontinence severity. A decrease from baseline indicates improvement. |
| Secondary | Fecal Incontinence Quality of Life Scale (FIQL) Scores Comparison | Measured at baseline and 1-,4-, and 12-month. | This outcome measure assesses the impact of fecal incontinence on patients' quality of life using the FIQL. The FIQL is a patient-reported outcome measure (PROM) that evaluates four domains of quality of life: lifestyle, coping/behavior, depression/self-perception, and embarrassment. It consists of 4 questions and 29 items, with various response categories and scoring methods. Scale Range: The FIQL does not provide an overall score.The FIQL includes a range of response options across its items, from 1 to 4 for most items, 1 to 5 for one item, and 1 to 6 for another. Lower scores indicate lower quality of life. Score Interpretation: Higher domain scores indicate better fecal incontinence-related quality of life. |
| Secondary | Bristol Stool Scale Scores Comparison | Measured at baseline and 1-,4-, and 12-month. | This measure will compare the Bristol Stool Scale scores between the two groups. Bristol Stool Scale Details: Unabbreviated Scale Title: Bristol Stool Scale Scale Range: 1-7 Score Interpretation: The scale classifies the form of human feces into seven categories. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT06166615
GET https://conductscience.org/api/trials/v1/NCT06166615/registered