Cow Milk AllergyPhase 3COMETENCT02351531
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
A Phase 3 study testing Extensively Hydrolyzed formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 3 sites in 3 countries.
Trial summary
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Extensively Hydrolyzed formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2013to Dec 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between 1 and 12 months old
- having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
- whose parent(s) signed the informed consent form
Who cannot join
- Infants mainly or exclusively breastfed,
- Infants having a weight at inclusion < 2500g,
- Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- Infants fed an amino acid based formula
- Infants who had an anaphylactic reaction in the past,
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.
- Conditions
- Cow Milk Allergy
- Being tested
- Extensively Hydrolyzed formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensively Hydrolyzed formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| New Thickened Extensively Hydrolyzed formula | Experimental | Not described Receives: Dietary Supplement: Extensively Hydrolyzed formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients dropped out for intolerance
Measured: 2 weeks
Secondary outcomes (3)
Cow's milk protein hypersensitivity score
Measured: 2 weeks
Growth (weight, height, head circumference)
Measured: 3 months
Growth (weight, height, head circumference)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cow Milk AllergyStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351531
- Sponsor's protocol ID
- UP-2013-02
- Acronym
- COMETE
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.
PubMed 27430981
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
- ClinicalTrials.gov ID
- NCT02351531
- Acronym / sponsor ID
- COMETE / UP-2013-02
- Conditions
- Cow Milk Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 30 Jan 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 the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.
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 Extensively Hydrolyzed formula | Experimental | Dietary Supplement: Extensively Hydrolyzed formula |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- between 1 and 12 months old
- having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
- whose parent(s) signed the informed consent form
Key exclusion criteria (5 listed)
- Infants mainly or exclusively breastfed,
- Infants having a weight at inclusion < 2500g,
- Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- Infants fed an amino acid based formula
- Infants who had an anaphylactic reaction in the past,
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 |
|---|---|---|
| Extensively Hydrolyzed formula | Dietary supplement | New Thickened Extensively Hydrolyzed formula |
Primary outcome
Number of patients dropped out for intolerance
Time frame: 2 weeks
3 secondary outcomes
Cow's milk protein hypersensitivity score
Time frame: 2 weeks
Growth (weight, height, head circumference)
Time frame: 3 months
Growth (weight, height, head circumference)
Time frame: 4 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 30 Jan 2015.
- Derived from this study: PubMed 27430981Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extensively Hydrolyzed formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 3 sites in 3 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 3 inclusion and 5 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 30 Jan 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, Italy. 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 patients dropped out for intolerance (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351531, which also lists 1 linked publication.
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 30 Jan 2015.