Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Kiddi® Pharmaton Fizz, effervescent tablets; Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula; Drug: Comparator product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02184325

1129.2

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Increased calcium blood concentration, or an increased calcium-excretion
• Evident states of protein deficiency
• Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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96 participants in 3 patient groups

Kiddi® Pharmaton Fizz, effervescent tablets

Experimental group

Description:

with reduced amount of minerals

Treatment:

Drug: Kiddi® Pharmaton Fizz, effervescent tablets

Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

Active Comparator group

Treatment:

Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

Comparator product

Active Comparator group

Description:

in the form of a product that is a market leader

Treatment:

Drug: Comparator product