<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02184325</url>
  </required_header>
  <id_info>
    <org_study_id>1129.2</org_study_id>
    <nct_id>NCT02184325</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets,&#xD;
      in children of 6 to 14 years, comparing a given formula with an improved one with reduced&#xD;
      mineral content (qualitatively equivalent to the first one) and a comparator product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1999</start_date>
  <primary_completion_date type="Actual">February 2000</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of total drug-related adverse events</measure>
    <time_frame>up to 19 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of all individual drug-related adverse events</measure>
    <time_frame>up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of overall tolerability and acceptance on a 4-point verbal rating scale</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Kiddi® Pharmaton Fizz, effervescent tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>with reduced amount of minerals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in the form of a product that is a market leader</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kiddi® Pharmaton Fizz, effervescent tablets</intervention_name>
    <arm_group_label>Kiddi® Pharmaton Fizz, effervescent tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula</intervention_name>
    <arm_group_label>Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Comparator product</intervention_name>
    <description>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</description>
    <arm_group_label>Comparator product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of both sexes aged between 6 and 14 years, inclusive&#xD;
&#xD;
          -  Children, healthy or during convalescence, for which prevention or treatment of&#xD;
             marginal vitamin deficits is indicated&#xD;
&#xD;
          -  Willingness of the children and parents to give their written informed consent,&#xD;
             according to Good Clinical Practice and local regulations&#xD;
&#xD;
          -  Pregnant children will not be excluded&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has taken medications containing vitamins A or D, retinoids, or iron during the 4&#xD;
             weeks preceding the study enrolment&#xD;
&#xD;
          -  Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant&#xD;
             treatment with any drug that may influence the trial symptomatology, and may interfere&#xD;
             with the evaluation of the safety of the test drug&#xD;
&#xD;
          -  Participation in other clinical trials within the last 4 weeks and concurrent&#xD;
             participation in another clinical trial&#xD;
&#xD;
          -  Relevant allergy or kown hypersensitivity to one of the ingredients of the&#xD;
             investigational drug&#xD;
&#xD;
          -  Has any serious disorder that may interfere with the participation to the trial&#xD;
&#xD;
          -  Malabsorption syndrome, liver and/or renal diseases or juvenile diabetes&#xD;
&#xD;
          -  Increased calcium blood concentration, or an increased calcium-excretion&#xD;
&#xD;
          -  Evident states of protein deficiency&#xD;
&#xD;
          -  Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1129/1129.2_U00-0170.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184325
org study id: 1129.2
nct id: NCT02184325
lead sponsor: 
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Incidence of total drug-related adverse events
time frame: up to 19 days
measure: Incidence of all individual drug-related adverse events
time frame: up to 19 days
measure: Assessment of overall tolerability and acceptance on a 4-point verbal rating scale
time frame: up to day 19
arm group label: Kiddi® Pharmaton Fizz, effervescent tablets
arm group type: Experimental
description: with reduced amount of minerals
arm group label: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
arm group type: Active Comparator
arm group label: Comparator product
arm group type: Active Comparator
description: in the form of a product that is a market leader
intervention type: Drug
intervention name: Kiddi® Pharmaton Fizz, effervescent tablets
arm group label: Kiddi® Pharmaton Fizz, effervescent tablets
intervention type: Drug
intervention name: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
arm group label: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
intervention type: Drug
intervention name: Comparator product
description: 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
arm group label: Comparator product
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1129/1129.2_U00-0170.pdf
description: Related Info
responsible party type: Sponsor