Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

Gastroesophageal Reflux Clinical Trial

— SONAR  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425423
• Other study ID #: 2013-01-SONAR
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2015
• Last updated: April 23, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: United Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéBelgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Months

Eligibility

Inclusion Criteria:

Infants :

• Aged = 5 months old

• fully formula fed

• with at least 5 episodes of regurgitation per day

Exclusion Criteria:

• Breast fed infants

• Infants presenting symptoms of a complicated gastroesophageal reflux

• Infants presenting intestinal disorders

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Dietary Supplement:
• New thickened formula

Locations

Country	Name	City	State
Belgium	Pediatricians	Belgium
Belgium	Universitair Ziekenhuis	Brussel
France	Pediatricians	France

Sponsors (1)

Lead Sponsor	Collaborator
United Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of regurgitation per day		14 days	No
Secondary	Regurgitation score		14 days	No
Secondary	Regurgitation score		3 months	No
Secondary	Digestive tolerance (stools' number and consistency)	Digestive tolerance of the formula assessed through stools' number and consistency	14 days	No
Secondary	Digestive tolerance (stools' number and consistency)	Digestive tolerance of the formula assessed through stools' number and consistency	3 months	No
Secondary	Growth parameters (Weight, height and head circumference)	Weight, height and head circumference	3 months	No