Efficacy of Ondansetron in LARS Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2022
• Main ID: NCT03182179
• Date of registration: 07/06/2017
• Prospective Registration: No
• Primary sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Public title: Efficacy of Ondansetron in LARS Treatment Hodolar
• Scientific title: Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study
• Date of first enrolment: November 1, 2016
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03182179
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Dimitri Christoforidis, Prof.
• Affiliation: Ospedale Regionale di Lugano, Civico e Italiano

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years

- Patients willing and able to comply with the study procedures

- Female patients of childbearing potential must agree to use a reliable method of
contraception

- Written informed consent Patients who have undergone low anterior resection (LAR) for
rectal cancer in the last 2 years provided that at least 4 weeks have elapsed since
recanalization and 4 weeks have elapsed since any chemo- and/or radiotherapy

- Presence of functioning anastomosis

- Presence of significant LARS symptoms assessed by LARS Score

Exclusion Criteria:

- Known hypersensitivity or allergy to Ondansetron

- Previous Ondansetron antiemetic therapy completed less than 4 weeks before study entry

- Antitumor chemotherapy or radiotherapy completed less than 4 weeks before study entry

- Congenital long Q-T syndrome

- Ongoing treatment with drugs causing prolongation of the Q-T interval

- Uncorrected hypokalemia or hypomagnesemia

- Women who are pregnant or breast feeding or are willing to become pregnant during the
study

- Clinically significant concomitant disease states or anastomotic complications which
could impair the ability of the patient to participate in the trial

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rectal Cancer

Intervention(s)

Drug: Ondansetron 4 MG

Drug: Placebo

Primary Outcome(s)

Change in LARS score [Time Frame: 10 wks]

Secondary Outcome(s)

Irritable Bowel Syndrome-Quality of Life [Time Frame: 10 wks]

Vaizey (St. Mark's) score [Time Frame: 10 wks]

Secondary ID(s)

ORL-CHIR-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors