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

Anterior Resection Syndrome Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02869984
• Other study ID #: 1604-095-755
• Status: Not yet recruiting
• Phase: Phase 0
• First received: August 10, 2016
• Last updated: August 12, 2016
• Start date: August 2016

Study information

• Verified date: August 2016
• Source: Seoul National University Hospital
• Contact: Kyu Joo Park, MD, PhD
• Phone: +82-2-2072-2901
• Email: kjparkmd[@]plaza.snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Resection Syndrome
• Syndrome

Intervention

Drug:
• Ramosetron

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A ST

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	low anterior resection syndrome score	questionnaire with comparison of frequency or urgency	4 weeks	No
Secondary	Quality of Life score	EORTC QLQ C30 (Korean version, validated)	4 weeks	Yes