<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/NCT01698645</url>
  </required_header>
  <id_info>
    <org_study_id>CP070/12</org_study_id>
    <nct_id>NCT01698645</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction and Quality of Life Impact - PecFent®</brief_title>
  <acronym>Qualipec</acronym>
  <official_title>A Spanish , Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Archimedes Development Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Archimedes Development Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      National multicenter, prospective, observational study in cancer patients with chronic&#xD;
      background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic&#xD;
      condition by a specialist in the treatment of cancer pain conditions.&#xD;
&#xD;
      • Study objectives include assessment of early treatment satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">December 2014</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>Satisfaction</measure>
    <time_frame>Satisfaction will be assessed approximately 1 hour after each breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7</time_frame>
    <description>Satisfaction will be assessed using a 4-point Likert scale.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Breakthrough Cancer Pain</condition>
  <arm_group>
    <arm_group_label>PecFent®</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PecFent® (fentanyl) nasal spray</intervention_name>
    <arm_group_label>PecFent®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer patients with breakthrough pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (aged ≥18 years) with cancer&#xD;
&#xD;
          -  Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic&#xD;
             background pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yolanda Riesgo, MD</last_name>
    <phone>+ 34 913510373</phone>
    <email>yolandariesgo@archimedespharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hernan Cortes, MD</last_name>
      <phone>+ 34 913 908 349</phone>
      <email>hcortes.hdoc@salud.madrid.org</email>
    </contact>
    <investigator>
      <last_name>Hernan Cortes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>July 10, 2013</last_update_submitted>
  <last_update_submitted_qc>July 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>PecFent</keyword>
  <keyword>Lazanda</keyword>
  <keyword>fentanyl</keyword>
  <keyword>intranasal</keyword>
  <keyword>breakthrough cancer pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</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/NCT01698645
org study id: CP070/12
nct id: NCT01698645
lead sponsor: 
has dmc: No
National multicenter, prospective, observational study in cancer patients with chronic
      background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic
      condition by a specialist in the treatment of cancer pain conditions.

      • Study objectives include assessment of early treatment satisfaction.
observational model: Cohort
time perspective: Prospective
measure: Satisfaction
time frame: Satisfaction will be assessed approximately 1 hour after each breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7
description: Satisfaction will be assessed using a 4-point Likert scale.
arm group label: PecFent®
intervention type: Drug
intervention name: PecFent® (fentanyl) nasal spray
arm group label: PecFent®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yolanda Riesgo, MD
phone: + 34 913510373
email: yolandariesgo@archimedespharma.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Cancer Pain
mesh term: Fentanyl