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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Kiddi® Pharmaton Fizz, effervescent tablets; Drug: Comparator product

• Registration Number: NCT02184325
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Primary Completion: 2000-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Kiddi® Pharmaton Fizz, effervescent tablets	Kiddi® Pharmaton Fizz, effervescent tablets	with reduced amount of minerals
Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula	Kiddi® Pharmaton Fizz, effervescent tablets	-
Comparator product	Comparator product	in the form of a product that is a market leader

Primary Outcome Measures

Name	Time	Method
Incidence of total drug-related adverse events	up to 19 days

Secondary Outcome Measures

Name	Time	Method
Incidence of all individual drug-related adverse events	up to 19 days
Assessment of overall tolerability and acceptance on a 4-point verbal rating scale	up to day 19