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

Primary Purpose

Gastroesophageal Reflux

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

New thickened formula

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux

Eligibility Criteria

undefined - 5 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pediatricians
Universitair Ziekenhuis
Pediatricians

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New thickened infant formula

Arm Description

Outcomes

Primary Outcome Measures

Number of episodes of regurgitation per day

Secondary Outcome Measures

Regurgitation score

Digestive tolerance (stools' number and consistency)

Digestive tolerance of the formula assessed through stools' number and consistency

Digestive tolerance (stools' number and consistency)

Digestive tolerance of the formula assessed through stools' number and consistency

Growth parameters (Weight, height and head circumference)

Weight, height and head circumference

Full Information

NCT ID

NCT02425423

First Posted

April 20, 2015

Last Updated

April 23, 2015

Sponsor

United Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02425423

Brief Title

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

Acronym

SONAR

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

New thickened infant formula

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

New thickened formula

Primary Outcome Measure Information:

Title

Number of episodes of regurgitation per day

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Regurgitation score

Time Frame

14 days

Title

Regurgitation score

Time Frame

3 months

Title

Digestive tolerance (stools' number and consistency)

Description

Digestive tolerance of the formula assessed through stools' number and consistency

Time Frame

14 days

Title

Digestive tolerance (stools' number and consistency)

Description

Digestive tolerance of the formula assessed through stools' number and consistency

Time Frame

3 months

Title

Growth parameters (Weight, height and head circumference)

Description

Weight, height and head circumference

Time Frame

3 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

5 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yvan Vandenplas, MD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatricians

City

Belgium

Country

Belgium

Facility Name

Universitair Ziekenhuis

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Pediatricians

City

France

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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