5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for... | NCT05577845

Studies
5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)

NCT05577845

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Apr 25, 2023Actual

Enrollment

212Estimated

Phase

Not Applicable

Conditions

LARS - Low Anterior Resection Syndrome

Interventions

Ramosetron

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2023Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2032Estimated

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Oct 11, 2022

First Posted Date

Oct 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2023

Last Update Posted Date

Apr 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ryoo, Seung-Bum, Clinical Associate Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

212Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ramosetron	Experimental		Drug: Ramosetron
Loperamide	Active Comparator		Drug: Ramosetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug	Ramosetron, 4 weeks	Loperamide Ramosetron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
EORTC QLQ-C30 score	Quality of life surveillance	0 weeks
EORTC QLQ-C30 score	Quality of life surveillance	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul	Jongro-gu	03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094123	Low Anterior Resection Syndrome

Ancestor Terms

ID	Term
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C071315	ramosetron

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided