Skip to main content
Clinical Trials/TCTR20200415001
TCTR20200415001
Completed
Phase 1

The Efficacy of Baclofen to Treat Gastroesophageal Reflux disease in Children Aged 6 Months to 12 Years

Golestan University of Medical Sciences0 sites62 target enrollmentApril 15, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gastroesophageal Reflux symptom
Sponsor
Golestan University of Medical Sciences
Enrollment
62
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 15, 2020
End Date
August 27, 2019
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Golestan University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • all children aged 6 months to 12 years with GERD who had at least two of the following five symptoms for at least one month. These symptoms included vomiting immediately after feeding, the persistence of reflux symptoms despite other treatments, restlessness after feeding for one to three hours, apnea and respiratory distress after feeding, no weight gain or weight gain of less than 500 grams, or weight loss during the last month and refusal to feed

Exclusion Criteria

  • patients less than 6 months and more than 12 years, patients taking baclofen for reasons other than GERD, patients with a history of anti\-reflux surgery, patients with endoscopic evidence of Helicobacter pylori gastritis or eosinophilic esophagitis, patients with evidence of gastroparesis radiography and lack of parental consent to participate in the study

Outcomes

Primary Outcomes

Not specified

Similar Trials