<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/NCT02188472</url>
  </required_header>
  <id_info>
    <org_study_id>PEN1011</org_study_id>
    <nct_id>NCT02188472</nct_id>
  </id_info>
  <brief_title>Pentriox - Induction of Oxidative Stress</brief_title>
  <acronym>PENTRIOX</acronym>
  <official_title>PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henrik Enghusen Poulsen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Klinisk Biokemisk Afdeling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinisk farmakologisk Afdeling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sektion for Biomedicin Institut for Veterinær Patobiologi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and&#xD;
      trimethoprim's possible induction of oxidative stress in human cells. The induction is&#xD;
      examined by comparing changes in oxidative stress in the treatment group with the change in a&#xD;
      placebo group. The study is a randomized-based placebo-controlled study. Each treatment group&#xD;
      consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or&#xD;
      placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and&#xD;
      8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug&#xD;
      treatment with placebo. The results will be published.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">February 2011</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary excretion of 8-oxoguanosine (nmol/24h)</measure>
    <time_frame>Change from Baseline after seven days of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)</measure>
    <time_frame>Change from Baseline after seven days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malondialdehyde</measure>
    <time_frame>At the screening visit and at the final visit</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Penicillin V</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Penicillin V 2 tablets of 330 mg twice dayly for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trimethoprim</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 Tablet Trimethoprim of 100 mg twice daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 Placebo Tablets twice daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Penicillin V</intervention_name>
    <description>Penicillin V: 2 x 330mg tablets should be taken twice daily</description>
    <arm_group_label>Penicillin V</arm_group_label>
    <other_name>Penicillin V, Pancillin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimethoprim</intervention_name>
    <description>Trimopan: 2 x 100mg tablets should be taken twice daily</description>
    <arm_group_label>Trimethoprim</arm_group_label>
    <other_name>Trimethoprim, Trimopan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo: 2 tablets should be taken twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  healthy men&#xD;
&#xD;
          -  non-smoker&#xD;
&#xD;
          -  18-35 years&#xD;
&#xD;
          -  BMI: 18-30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  high blood pressure&#xD;
&#xD;
          -  allergies towards any of the tested medicine&#xD;
&#xD;
          -  galactose-intolerance&#xD;
&#xD;
          -  abnormal lipid profile&#xD;
&#xD;
          -  CRP &gt; 10&#xD;
&#xD;
          -  Glucose/galactose-malabsorption&#xD;
&#xD;
          -  Use of medications and herbal remedies that affect/are affected by v-penicillin and&#xD;
             trimethoprim&#xD;
&#xD;
          -  intake of narcotics 2 months prior to trial&#xD;
&#xD;
          -  intake of supplements 1 month prior to trial&#xD;
&#xD;
          -  bronchial asthma&#xD;
&#xD;
          -  allergies&#xD;
&#xD;
          -  heart deficiencies&#xD;
&#xD;
          -  brady cardia&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  hypo-potassium&#xD;
&#xD;
          -  phenylketonuria&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik E Poulsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department head</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 1, 2010</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Henrik Enghusen Poulsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Oxidative Stress</keyword>
  <keyword>antibiotics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trimethoprim</mesh_term>
    <mesh_term>Penicillins</mesh_term>
    <mesh_term>Penicillin V</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/NCT02188472
org study id: PEN1011
nct id: NCT02188472
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and
      trimethoprim's possible induction of oxidative stress in human cells. The induction is
      examined by comparing changes in oxidative stress in the treatment group with the change in a
      placebo group. The study is a randomized-based placebo-controlled study. Each treatment group
      consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or
      placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and
      8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug
      treatment with placebo. The results will be published.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Urinary excretion of 8-oxoguanosine (nmol/24h)
time frame: Change from Baseline after seven days of treatment
measure: Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)
time frame: Change from Baseline after seven days of treatment
measure: Malondialdehyde
time frame: At the screening visit and at the final visit
arm group label: Penicillin V
arm group type: Active Comparator
description: Penicillin V 2 tablets of 330 mg twice dayly for 7 days
arm group label: Trimethoprim
arm group type: Active Comparator
description: 2 Tablet Trimethoprim of 100 mg twice daily for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 Placebo Tablets twice daily for 7 days
intervention type: Drug
intervention name: Penicillin V
description: Penicillin V: 2 x 330mg tablets should be taken twice daily
arm group label: Penicillin V
other name: Penicillin V, Pancillin
intervention type: Drug
intervention name: Trimethoprim
description: Trimopan: 2 x 100mg tablets should be taken twice daily
arm group label: Trimethoprim
other name: Trimethoprim, Trimopan
intervention type: Drug
intervention name: Placebo
description: Placebo: 2 tablets should be taken twice daily
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Henrik E Poulsen, MD
role: Principal Investigator
affiliation: Department head
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Henrik Enghusen Poulsen
investigator title: Professor
mesh term: Trimethoprim
mesh term: Penicillins
mesh term: Penicillin V