<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/NCT01718639</url>
  </required_header>
  <id_info>
    <org_study_id>INQ/012512</org_study_id>
    <nct_id>NCT01718639</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn</brief_title>
  <official_title>Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InQpharm Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InQpharm Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical&#xD;
      trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in&#xD;
      postprandial heartburn.&#xD;
&#xD;
      The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in&#xD;
      terms of efficacy for postprandial heartburn treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms</measure>
    <time_frame>Measured up to 30 minutes</time_frame>
    <description>The subject will be provided with a stopwatch started by the study staff at the time of investigational product application</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of efficacy</measure>
    <time_frame>Up to 4 hours per crossover</time_frame>
    <description>The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with &quot;very good&quot;, &quot;good&quot;, &quot;moderate&quot; and &quot;poor&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Postprandial Heartburn</condition>
  <arm_group>
    <arm_group_label>IQP-LH-101 tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 chewable tablets to be chewed thoroughly before swallowing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IQP-LH-101 liquid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 liquid sachets to be emptied into the mouth and consumed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 tablet to be swallowed with water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IQP-LH-101 tablet</intervention_name>
    <description>Oral medical device in the form of a chewable tablet</description>
    <arm_group_label>IQP-LH-101 tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IQP-LH-101 liquid</intervention_name>
    <description>Oral medical device in the form of a liquid</description>
    <arm_group_label>IQP-LH-101 liquid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the&#xD;
             study (at least 2 times a week)&#xD;
&#xD;
          -  Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal&#xD;
             disorders&#xD;
&#xD;
          -  Written informed consent is a prerequisite for subject enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrointestinal bleeding within 12 months prior to the study&#xD;
&#xD;
          -  Difficulty swallowing (dysphagia)&#xD;
&#xD;
          -  History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or&#xD;
             gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's&#xD;
             oesophagus or systemic sclerosis&#xD;
&#xD;
          -  Participation in other studies within the last 30 days prior to entry or during the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Weißenseerweg 111</name>
      <address>
        <city>Berlin</city>
        <zip>10369</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>March 7, 2013</last_update_submitted>
  <last_update_submitted_qc>March 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heartburn</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718639
org study id: INQ/012512
nct id: NCT01718639
lead sponsor: 
has dmc: No
This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical
      trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in
      postprandial heartburn.

      The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in
      terms of efficacy for postprandial heartburn treatment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms
time frame: Measured up to 30 minutes
description: The subject will be provided with a stopwatch started by the study staff at the time of investigational product application
measure: Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product
time frame: Up to 4 hours
description: The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.
measure: Evaluation of efficacy
time frame: Up to 4 hours per crossover
description: The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor").
measure: Adverse events
time frame: Up to 4 weeks
description: The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.
arm group label: IQP-LH-101 tablet
arm group type: Active Comparator
description: 4 chewable tablets to be chewed thoroughly before swallowing
arm group label: IQP-LH-101 liquid
arm group type: Active Comparator
description: 2 liquid sachets to be emptied into the mouth and consumed.
arm group label: Placebo
arm group type: Placebo Comparator
description: 1 tablet to be swallowed with water.
intervention type: Device
intervention name: IQP-LH-101 tablet
description: Oral medical device in the form of a chewable tablet
arm group label: IQP-LH-101 tablet
intervention type: Device
intervention name: IQP-LH-101 liquid
description: Oral medical device in the form of a liquid
arm group label: IQP-LH-101 liquid
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Heartburn