Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome

August 12, 2016 updated by: Kyu Joo Park, Seoul National University Hospital

Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency.

We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The patients who undergo sphincter saving surgery for rectal cancer

Exclusion Criteria:

  • recurred rectal cancer
  • rectal cancer with distant metastasis
  • permanent stoma formation
  • postoperative concurrent chemoradiotherapy
  • uncontrolled medical disease
  • inflammatory bowel disease
  • uncontrolled constipation
  • preoperative incontinence (LARS score, more than 20)
  • allergic to intervention drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No treatment
Experimental: Treatment
ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer
Drug: Ramosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
low anterior resection syndrome score
Time Frame: 4 weeks
questionnaire with comparison of frequency or urgency
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life score
Time Frame: 4 weeks
EORTC QLQ C30 (Korean version, validated)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Dong-A ST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604-095-755

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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