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

April 23, 2015 updated by: United Pharmaceuticals
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Belgium, Belgium
        • Pediatricians
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis
  • France
      • France, France
        • Pediatricians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New thickened infant formula
Dietary supplement: New thickened formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of episodes of regurgitation per day
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regurgitation score
Time Frame: 14 days
14 days
Regurgitation score
Time Frame: 3 months
3 months
Digestive tolerance (stools' number and consistency)
Time Frame: 14 days
Digestive tolerance of the formula assessed through stools' number and consistency
14 days
Digestive tolerance (stools' number and consistency)
Time Frame: 3 months
Digestive tolerance of the formula assessed through stools' number and consistency
3 months
Growth parameters (Weight, height and head circumference)
Time Frame: 3 months
Weight, height and head circumference
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Pharmaceuticals

Investigators

  • Principal Investigator: Yvan Vandenplas, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-01-SONAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux

Clinical Trials on New thickened formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe