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

NCT02184325 | Completed Phase 2

• 1 other identifier: 1129.2
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of total drug-related adverse events

  up to 19 days

Secondary Outcomes (2)

• 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

Study Arms (3)

Kiddi® Pharmaton Fizz, effervescent tablets

EXPERIMENTAL

with reduced amount of minerals

Drug: Kiddi® Pharmaton Fizz, effervescent tablets

Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

ACTIVE COMPARATOR

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

Comparator product

ACTIVE COMPARATOR

in the form of a product that is a market leader

Drug: Comparator product

Interventions

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 product DRUG

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

Comparator product

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 9, 2014
• Study Start: November 1, 1999
• Primary Completion: February 1, 2000
• Last Updated: July 14, 2014

Record last verified: 2014-07