Which one is more effective in cyclic vomiting syndrome treatment? Topitamate or Amitriptyline ?

Comparison the effect of Topiramate and Amitriptyline Prophylactic therapy on cyclic vomiting syndrome in Pediatrics

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015102316844N2

Enrollment

Registered

2016-02-27

Start date

2016-02-14

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cyclical vomiting syndrome. Nausea and vomiting

Interventions

Intervention 1: Intervention group: In one group we will start topiramate for patients with the dosage of 1-2 mg/kg daily. Patients won't be aware of their drugs. The medication will be used for at li

Treatment - Drugs

Intervention group: In one group we will start topiramate for patients with the dosage of 1-2 mg/kg daily. Patients won't be aware of their drugs. The medication will be used for at list three months

Control group: In the other group we will start Amitriptyline for patients with the dosage of 1 mg/kg daily. The medication will be used for at list three months during the study. The medication is p

Eligibility

Sex/Gender

All

Age

3 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children 3-15 years old with diagnosis of cyclic vomiting syndrome (based on Rome III criteria: 1 Stereotypical episodes of vomiting regarding onset (acute) and duration (less than 1 week); 2) Three or more discrete episodes in the prior year; and 3) Absence of nausea and vomiting between episodes and absence of metabolic, gastrointestinal, central nervous system structural or biochemical disorders); Normal Neurological and Developmental examination Exclusion criteria: Known metabolic disease; Obstructive disease of gastrointestinal or urinary system; Patients who don't give consent to participate in the study or want to leave the study anytime.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of cyclic vomiting syndrome. Timepoint: for 3 months after starting the medication. Patients are followed every two weeks after starting the medication. Method of measurement: questionnaire (evaluating number of attacks and duration of attacks).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Bagherian

Isfahan University of Medical Sciences, Child Growth and Development Research Center

shervin.badihian@gmail.com+98 31 3627 7831

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026