Milk HypersensitivityNCT00938483
Tolerability and Safety of An Infant Formula
A study testing Nutramigen Lipil (Infant formula) in people with Milk Hypersensitivity, run by Perrigo Nutritionals.
Trial summary
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy. Read more about this study
- Who is it for?
- Ages 1 day to 12 weeks
- Conditions the study is for
- Milk Hypersensitivity
- What is being tested?
- Nutramigen Lipil (Infant formula)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jan 2009
- Phase
- Interventional
- 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 day to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinically diagnosed CMA
- </= 12 weeks at time of study entry
- full-term infant
- must be willing to use provided formula as sole source of nutrition
- other than CMA, infant must be otherwise healthy
Who cannot join
- underlying or confounding gastrointestinal abnormalities
- infants born from an addictive situation, HIV positive
- if parent/guardian is considered likely to be non-compliant with the protocol requirements
About this study
Official title: A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
- Conditions
- Milk Hypersensitivity
- Being tested
- Nutramigen Lipil (Infant formula)
- Keywords
- infant formula, cow's milk allergy
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutramigen Lipil (Infant formula)Other
Also called Extensively hydrolyed infant formula (Nutramigen Lipil)
| Study group | Role | What they receive |
|---|---|---|
| Extensively hydrolyzed infant formula | Experimental | New extensively hydrolyzed formula, NPS-202 Receives: Other: Nutramigen Lipil (Infant formula) |
| Infant formula - Extensively hydrolyzed Nutramigen Lipil | Active comparator | Currently marketed extensively hydrolyzed formula (Nutramigen Lipil) Receives: Other: Nutramigen Lipil (Infant formula) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant reactivity to an extensively hydrolyzed infant formula
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk HypersensitivityStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perrigo Nutritionals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cynthia M Barber, PhD, Study director, Perrigo Nutritionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938483
- Sponsor's protocol ID
- CTP-0010
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT00938483
- Acronym / sponsor ID
- CTP-0010
- Conditions
- Milk Hypersensitivity
- Keywords
- infant formula, cow's milk allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Perrigo NutritionalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Jul 2009 (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 purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensively hydrolyzed infant formula | Experimental | Other: Nutramigen Lipil (Infant formula)New extensively hydrolyzed formula, NPS-202 |
| Infant formula - Extensively hydrolyzed Nutramigen Lipil | Active comparator | Other: Nutramigen Lipil (Infant formula)Currently marketed extensively hydrolyzed formula (Nutramigen Lipil) |
Who may qualify
- Ages
- 1 day to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- clinically diagnosed CMA
- </= 12 weeks at time of study entry
- full-term infant
- must be willing to use provided formula as sole source of nutrition
- other than CMA, infant must be otherwise healthy
Key exclusion criteria (3 listed)
- underlying or confounding gastrointestinal abnormalities
- infants born from an addictive situation, HIV positive
- if parent/guardian is considered likely to be non-compliant with the protocol requirements
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 |
|---|---|---|
| Nutramigen Lipil (Infant formula)Also: Extensively hydrolyed infant formula (Nutramigen Lipil) | Other | Extensively hydrolyzed infant formula, Infant formula - Extensively hydrolyzed Nutramigen Lipil |
Primary outcome
Infant reactivity to an extensively hydrolyzed infant formula
Time frame: 29 days
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 15 Jul 2009.
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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.
Cynthia M Barber, PhD study director
Perrigo Nutritionals
Questions about this trial
What is this clinical trial studying?
A study testing Nutramigen Lipil (Infant formula) in people with Milk Hypersensitivity, run by Perrigo Nutritionals.
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 5 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 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Infant reactivity to an extensively hydrolyzed infant formula (time frame: 29 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 15 Jul 2009; AzTrials last refreshed its copy on 7 Nov 2026.