NCT05577845

Brief Summary

Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
80mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Mar 2023Dec 2032

First Submitted

Initial submission to the registry

September 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Expected
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

September 28, 2022

Last Update Submit

April 24, 2023

Conditions

LARS - Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (2)

  • major Low Anterior Resection Syndrome (LARS)

    LARS score (0-20, no, 21-29, minor, 30-42, major)

    0 weeks

  • Difference of improvement of major Low Anterior Resection Syndrome (LARS)

    LARS score (0-20, no, 21-29, minor, 30-42, major)

    4 weeks

Secondary Outcomes (2)

  • EORTC QLQ-C30 score

    0 weeks

  • EORTC QLQ-C30 score

    4 weeks

Study Arms (2)

Ramosetron

EXPERIMENTAL
Drug: Ramosetron

Loperamide

ACTIVE COMPARATOR
Drug: Ramosetron

Interventions

RamosetronDRUG

Ramosetron, 4 weeks

LoperamideRamosetron

Eligibility Criteria

Age19 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mid and low rectal cancer (AV\<15cm)
  • stage II, III, preop long-course CCRT, then ileostomy repair
  • about 1\~12 months after operation (no stomy)
  • about 1\~6 months after ileostomy repair
  • major LARS

You may not qualify if:

  • recurred rectal cancer
  • stage IV
  • IBD
  • uncontrolled preoperative fecal incontinence or constipation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 13, 2022

Study Start

March 27, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2032

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

KR(1)