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
ConditionsGastroesophageal Reflux symptom
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.
Investigators
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
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