HealthyPhase 2NCT02184325
Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children
A Phase 2 study testing Kiddi® Pharmaton Fizz, effervescent tablets, Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula and Comparator product in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Kiddi® Pharmaton Fizz, effervescent tablets, Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula and Comparator product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Feb 2000
- Phase
- Phase 2
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of both sexes aged between 6 and 14 years, inclusive
- Children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated
- Willingness of the children and parents to give their written informed consent, according to Good Clinical Practice and local regulations
- Pregnant children will not be excluded
Who cannot join
- Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment
- Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug
- Participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial
- Relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug
- Has any serious disorder that may interfere with the participation to the trial
- Malabsorption syndrome, liver and/or renal diseases or juvenile diabetes
Show all 9Show fewer
- Increased calcium blood concentration, or an increased calcium-excretion
- Evident states of protein deficiency
- Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)
About this study
Official title: Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets, Comparing the Marketed Formula With an Improved One With a Reduced Mineral Amount, and a Comparator Product: a Double-blind, Controlled, Randomised, Three Arm Cross-over Study in Children
Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.
- Conditions
- Healthy
- Being tested
- Kiddi® Pharmaton Fizz, effervescent tablets, Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula, Comparator product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiddi® Pharmaton Fizz, effervescent tabletsDrug
Kiddi® Pharmaton Fizz, effervescent tablets: marketed formulaDrug
Comparator productDrug
active substances: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Manganese, Copper, Calcium, Magnesium, Phosphorous, Iron, Zinc, Sodium, Molybden
| Study group | Role | What they receive |
|---|---|---|
| Kiddi® Pharmaton Fizz, effervescent tablets | Experimental | with reduced amount of minerals Receives: Drug: Kiddi® Pharmaton Fizz, effervescent tablets |
| Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula | Active comparator | Not described Receives: Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula |
| Comparator product | Active comparator | in the form of a product that is a market leader Receives: Drug: Comparator product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of total drug-related adverse events
Measured: up to 19 days
Secondary outcomes (2)
Incidence of all individual drug-related adverse events
Measured: up to 19 days
Assessment of overall tolerability and acceptance on a 4-point verbal rating scale
Measured: up to day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startNov 1999
- Primary completionFeb 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184325
- Sponsor's protocol ID
- 1129.2
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets, Comparing the Marketed Formula With an Improved One With a Reduced Mineral Amount, and a Comparator Product: a Double-blind, Controlled, Randomised, Three Arm Cross-over Study in Children
- ClinicalTrials.gov ID
- NCT02184325
- Acronym / sponsor ID
- 1129.2
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Feb 2000 (actual)
- First posted
- 9 Jul 2014 (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.
Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kiddi® Pharmaton Fizz, effervescent tablets | Experimental | Drug: Kiddi® Pharmaton Fizz, effervescent tabletswith reduced amount of minerals |
| Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula | Active comparator | Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula |
| Comparator product | Active comparator | Drug: Comparator productin the form of a product that is a market leader |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of both sexes aged between 6 and 14 years, inclusive
- Children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated
- Willingness of the children and parents to give their written informed consent, according to Good Clinical Practice and local regulations
- Pregnant children will not be excluded
Key exclusion criteria (9 listed)
- Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment
- Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug
- Participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial
- Relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug
- Has any serious disorder that may interfere with the participation to the trial
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 |
|---|---|---|
| Kiddi® Pharmaton Fizz, effervescent tablets | Drug | Kiddi® Pharmaton Fizz, effervescent tablets |
| Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula | Drug | Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula |
| Comparator productactive substances: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Manganese, Copper, Calcium, Magnesium, Phosphorous, Iron, Zinc, Sodium, Molybden | Drug | Comparator product |
Primary outcome
Incidence of total drug-related adverse events
Time frame: up to 19 days
2 secondary outcomes
Incidence of all individual drug-related adverse events
Time frame: up to 19 days
Assessment of overall tolerability and acceptance on a 4-point verbal rating scale
Time frame: up to day 19
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kiddi® Pharmaton Fizz, effervescent tablets, Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula and Comparator product in people with Healthy, run by Boehringer Ingelheim.
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 9 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 14 Jul 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of total drug-related adverse events (time frame: up to 19 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 14 Jul 2014.