Gastroesophageal RefluxPhase 3SONARNCT02425423
Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula
A Phase 3 study testing New thickened formula in people with Gastroesophageal Reflux, run by United Pharmaceuticals at 3 sites in 2 countries.
Trial summary
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation. Read more about this study
- Who is it for?
- Ages Up to 5 months
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- New thickened formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2013to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants :
- Aged ≤ 5 months old
- fully formula fed
- with at least 5 episodes of regurgitation per day
Who cannot join
- Breast fed infants
- Infants presenting symptoms of a complicated gastroesophageal reflux
- Infants presenting intestinal disorders
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.
- Conditions
- Gastroesophageal Reflux
- Being tested
- New thickened formula
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New thickened formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| New thickened infant formula | Experimental | Not described Receives: Dietary Supplement: New thickened formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of regurgitation per day
Measured: 14 days
Secondary outcomes (5)
Regurgitation score
Measured: 14 days
Regurgitation score
Measured: 3 months
Digestive tolerance (stools' number and consistency)
Digestive tolerance of the formula assessed through stools' number and consistency
Measured: 14 days
Digestive tolerance (stools' number and consistency)
Digestive tolerance of the formula assessed through stools' number and consistency
Measured: 3 months
Growth parameters (Weight, height and head circumference)
Weight, height and head circumference
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvan Vandenplas, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425423
- Sponsor's protocol ID
- 2013-01-SONAR
- Acronym
- SONAR
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula
- ClinicalTrials.gov ID
- NCT02425423
- Acronym / sponsor ID
- SONAR / 2013-01-SONAR
- Conditions
- Gastroesophageal Reflux
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New thickened infant formula | Experimental | Dietary Supplement: New thickened formula |
Who may qualify
- Ages
- Up to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged ≤ 5 months old
- fully formula fed
- with at least 5 episodes of regurgitation per day
Key exclusion criteria (3 listed)
- Breast fed infants
- Infants presenting symptoms of a complicated gastroesophageal reflux
- Infants presenting intestinal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New thickened formula | Dietary supplement | New thickened infant formula |
Primary outcome
Number of episodes of regurgitation per day
Time frame: 14 days
5 secondary outcomes
Regurgitation score
Time frame: 14 days
Regurgitation score
Time frame: 3 months
Digestive tolerance (stools' number and consistency)
Time frame: 14 days
Digestive tolerance (stools' number and consistency)
Time frame: 3 months
Growth parameters (Weight, height and head circumference)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvan Vandenplas, MD principal investigator
Universitair Ziekenhuis Brussel
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing New thickened formula in people with Gastroesophageal Reflux, run by United Pharmaceuticals at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of regurgitation per day (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.