xml: <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/NCT05983042</url>
    </required_header>
    <id_info>
      <org_study_id>Riphah/IIMC/IRC/22/2072</org_study_id>
      <nct_id>NCT05983042</nct_id>
    </id_info>
    <brief_title>Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population</brief_title>
    <official_title>Effect of CYP2C9*3 rs 1057910 Polymorphism on the Efficacy and Tolerability of Ibuprofen After Molar Tooth Extraction in Pakistani Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this Observational study was to identify the effect of CYP2C9 gene polymorphism&#xD;
        in the Pakistani population. The main question it aims to answer were:&#xD;
  &#xD;
          -  to evaluate the effect of this genetic polymorphism on the clinical efficacy of&#xD;
             Ibuprofen&#xD;
  &#xD;
          -  to evaluate the effect of this genetic polymorphism on the clinical tolerability of&#xD;
             Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this observational study was to identify the effect of CYP2C9*3 gene polymorphism&#xD;
        in the Pakistani population, due to the high prevalence of this variant in the Pakistani&#xD;
        Population&#xD;
  &#xD;
        The main question it aims to answer were:&#xD;
  &#xD;
          -  to evaluate the effect of this genetic polymorphism on the clinical efficacy of&#xD;
             Ibuprofen&#xD;
  &#xD;
          -  to evaluate the effect of this genetic polymorphism on the clinical tolerability of&#xD;
             Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.&#xD;
  &#xD;
        The blood samples of the participants were taken and further genotyping was performed using&#xD;
        conventional tetraARMS PCR. The results were visualized by gel electrophoresis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the genetic variabilities in the clinical efficacy of ibuprofen after molar tooth extraction using a visual analog scale VAS</measure>
      <time_frame>three days</time_frame>
      <description>A Visual Analogue Scale (VAS) is one of the self-administered pain rating scales, to measure pain intensity. The pain was interpreted as no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate the genetic variabilities in the tolerability of ibuprofen after molar tooth extraction using the General Assessment of Side Effects GASE scale.</measure>
      <time_frame>three days</time_frame>
      <description>The self-rating scale General Assessment of Side Effects (GASE), is about the most frequent side effects in clinical trials of different drugs. Every symptom (dyspepsia, nausea, diarrhea) had to be answered twice: first, participants had to rate the intensity of this symptom during the last 3 days, and second, if this symptom was present, participants had to rate whether they attribute it to current drug intake.</description>
    </secondary_outcome>
    <enrollment type="Actual">200</enrollment>
    <condition>Healthy Volunteers</condition>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>Ibuprofen</intervention_name>
      <description>Ibuprofen 400mg three times a day for three days</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Venous blood was withdrawn, and DNA extraction was performed using Chelex method.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals who were advised for molar tooth extractions based on orthodontic, periodontal,&#xD;
          and endodontic indications&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pakistani individuals&#xD;
  &#xD;
            -  Absence of systemic diseases&#xD;
  &#xD;
            -  Extractions required based on orthodontic, periodontal, and endodontic indications&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of bleeding or gastrointestinal ulcers&#xD;
  &#xD;
            -  allergic to ibuprofen or other NSAIDs.&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ammarah Amjad, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ammarah Amjad</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <zip>46000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Ibuprofen</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983042
  org study id: Riphah/IIMC/IRC/22/2072
  nct id: NCT05983042
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this Observational study was to identify the effect of CYP2C9 gene polymorphism
        in the Pakistani population. The main question it aims to answer were:
  
          -  to evaluate the effect of this genetic polymorphism on the clinical efficacy of
             Ibuprofen
  
          -  to evaluate the effect of this genetic polymorphism on the clinical tolerability of
             Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.
  The goal of this observational study was to identify the effect of CYP2C9*3 gene polymorphism
        in the Pakistani population, due to the high prevalence of this variant in the Pakistani
        Population
  
        The main question it aims to answer were:
  
          -  to evaluate the effect of this genetic polymorphism on the clinical efficacy of
             Ibuprofen
  
          -  to evaluate the effect of this genetic polymorphism on the clinical tolerability of
             Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.
  
        The blood samples of the participants were taken and further genotyping was performed using
        conventional tetraARMS PCR. The results were visualized by gel electrophoresis.
  observational model: Cohort
  time perspective: Prospective
  measure: To evaluate the genetic variabilities in the clinical efficacy of ibuprofen after molar tooth extraction using a visual analog scale VAS
  time frame: three days
  description: A Visual Analogue Scale (VAS) is one of the self-administered pain rating scales, to measure pain intensity. The pain was interpreted as no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
  measure: To evaluate the genetic variabilities in the tolerability of ibuprofen after molar tooth extraction using the General Assessment of Side Effects GASE scale.
  time frame: three days
  description: The self-rating scale General Assessment of Side Effects (GASE), is about the most frequent side effects in clinical trials of different drugs. Every symptom (dyspepsia, nausea, diarrhea) had to be answered twice: first, participants had to rate the intensity of this symptom during the last 3 days, and second, if this symptom was present, participants had to rate whether they attribute it to current drug intake.
  intervention type: Genetic
  intervention name: Ibuprofen
  description: Ibuprofen 400mg three times a day for three days
  Venous blood was withdrawn, and DNA extraction was performed using Chelex method.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Ammarah Amjad, BDS
  role: Principal Investigator
  affiliation: Riphah International University
  facility: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Ibuprofen
  sharing ipd: No