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

July 11, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kiddi® Pharmaton Fizz, effervescent tablets
with reduced amount of minerals
Drug: Kiddi® Pharmaton Fizz, effervescent tablets
Active Comparator: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
Active Comparator: Comparator product
in the form of a product that is a market leader
Drug: Comparator product
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of total drug-related adverse events
Time Frame: up to 19 days
up to 19 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

February 1, 2000

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 1129.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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