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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02869984
• Collaborator: Dong-A ST (Other)
• Enrollment: 100
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anterior Resection Syndrome	Drug: Ramosetron	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Oct 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. low anterior resection syndrome score [4 weeks]

   questionnaire with comparison of frequency or urgency

Secondary Outcome Measures

1. Quality of Life score [4 weeks]

   EORTC QLQ C30 (Korean version, validated)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital
• Dong-A ST

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyu Joo Park, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02869984
• Other Study ID Numbers: 1604-095-755
• First Posted: Aug 17, 2016
• Last Update Posted: Aug 17, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Syndrome; Ramosetron

Study Results

No Results Posted as of Aug 17, 2016