<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/NCT02183649</url>
  </required_header>
  <id_info>
    <org_study_id>1265.1</org_study_id>
    <nct_id>NCT02183649</nct_id>
  </id_info>
  <brief_title>Tolerability and Potential ECG Effects After a Single Oral Dose of Pentoxyverine Citrate in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Phase I, Single-dose, Two-way Crossover Study to Investigate Tolerability and Potential ECG Effects After a Single Oral Dose of 192 mg Pentoxyverine Citrate (Corresponding to 121.5 mg Pentoxyverine Base) in Healthy Male and Female Volunteers (Randomised, Single-blind, Placebo-controlled)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The primary objective of this trial was to investigate the potential effects of pentoxyverine&#xD;
      on the ECGs of healthy subjects. A secondary objective was the exploration of safety and&#xD;
      tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the&#xD;
      explanation of ECG effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <primary_completion_date type="Actual">December 2009</primary_completion_date>
  <phase>Phase 1</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>changes from baseline in QTc interval</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of adverse events</measure>
    <time_frame>up to day 44</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure change from baseline</measure>
    <time_frame>up to day 44</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse rate change from baseline</measure>
    <time_frame>up to day 44</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of global tolerability by 4-point scale</measure>
    <time_frame>up to day 44</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>pentoxyverine citrate vs. placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects were allocated to receive both verum and placebo in randomised order</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pentoxyverine citrate</intervention_name>
    <arm_group_label>pentoxyverine citrate vs. placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>pentoxyverine citrate vs. placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female subjects according to the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (blood pressure (BP), pulse rate (PR)) 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          2. Age ≥21 and ≤45 years&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥18.5 and ≤29.9 kg/m²&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with GCP and the local legislation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including BP, PR, and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          2. Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          6. History of relevant orthostatic hypotension, fainting spells or blackouts.&#xD;
&#xD;
          7. Chronic or relevant acute infections&#xD;
&#xD;
          8. History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          9. Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
         10. Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval based on the knowledge at the time of protocol preparation within&#xD;
             10 days prior to administration or during the trial&#xD;
&#xD;
         11. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         12. Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
         13. Inability to refrain from smoking on trial days&#xD;
&#xD;
         14. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         15. Drug abuse&#xD;
&#xD;
         16. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         17. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         18. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         19. Inability to comply with dietary regimen of trial site&#xD;
&#xD;
         20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms);&#xD;
&#xD;
         21. A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 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/1265/1265.1_U10-1901-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carbetapentane</mesh_term>
  </intervention_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/NCT02183649
org study id: 1265.1
nct id: NCT02183649
lead sponsor: 
The primary objective of this trial was to investigate the potential effects of pentoxyverine
      on the ECGs of healthy subjects. A secondary objective was the exploration of safety and
      tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the
      explanation of ECG effects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: changes from baseline in QTc interval
time frame: up to 24 hours
measure: number of adverse events
time frame: up to day 44
measure: Blood pressure change from baseline
time frame: up to day 44
measure: Pulse rate change from baseline
time frame: up to day 44
measure: assessment of global tolerability by 4-point scale
time frame: up to day 44
arm group label: pentoxyverine citrate vs. placebo
arm group type: Experimental
description: All subjects were allocated to receive both verum and placebo in randomised order
intervention type: Drug
intervention name: pentoxyverine citrate
arm group label: pentoxyverine citrate vs. placebo
intervention type: Drug
intervention name: Placebo
arm group label: pentoxyverine citrate vs. placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1265/1265.1_U10-1901-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Carbetapentane