<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/NCT03809455</url>
  </required_header>
  <id_info>
    <org_study_id>UC-0106/1607 SdS 02 FARADI</org_study_id>
    <nct_id>NCT03809455</nct_id>
  </id_info>
  <brief_title>Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients</brief_title>
  <acronym>FARADI</acronym>
  <official_title>Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNICANCER</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate&#xD;
      is used outside of its marketing authorisation) Patients will be enrolled in an observational&#xD;
      cohort when the fentanyl citrate is used according to its marketing authorisation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective (phase II trial):&#xD;
&#xD;
      Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain&#xD;
      caused by positional requirements of a diagnostic or therapeutic intervention/examination in&#xD;
      cancer patients who do not meet the prescription criteria for fentanyl citrate's marketing&#xD;
      authorisation, as follows:&#xD;
&#xD;
        -  Patients having received less than 60 mg of slow-release/extended-release morphine.&#xD;
&#xD;
        -  Patients having received slow-release/extended-release morphine for less than 7 days.&#xD;
&#xD;
        -  Patients who have not received any opioid treatment.&#xD;
&#xD;
      Primary objective (cohort):&#xD;
&#xD;
      Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain&#xD;
      caused by positional requirements of a diagnostic or therapeutic intervention/examination in&#xD;
      cancer patients when used within the marketing authorisation, as follows:&#xD;
&#xD;
        -  Patients having at least 60 mg of slow-release/extended-release morphine.&#xD;
&#xD;
        -  Patients having received slow-release/extended-release morphine for at least 7 days.&#xD;
&#xD;
        -  Patients who have already received an opioid treatment (at least equivalent to 60 mg&#xD;
           /day of oral morphine) for chronic cancer-related pain for at least 7 days.&#xD;
&#xD;
      Secondary objectives (phase II and cohort):&#xD;
&#xD;
        -  Evaluate the tolerance of the administration of fentanyl citrate when used to alleviate&#xD;
           breakthrough pain caused by positional requirements of a diagnostic or therapeutic&#xD;
           intervention/examination in cancer patients.&#xD;
&#xD;
        -  Evaluate the efficacy of fentanyl citrate for reducing pain.&#xD;
&#xD;
        -  Evaluate the efficacy of fentanyl citrate for reducing anxiety.&#xD;
&#xD;
        -  Evaluate the percentage of relief and patients' satisfaction related to the&#xD;
           administration of fentanyl citrate.&#xD;
&#xD;
      Secondary objectives (phase II only):&#xD;
&#xD;
      • Describe the reasons why the diagnostic or therapeutic intervention/examination failed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was cancelled by Sponsor.&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 1, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation.&#xD;
The study will randomise patients (2:1; FAR Arm: Placebo Arm)&#xD;
Stratified by:&#xD;
Centre&#xD;
Type of examination: diagnostic (PET-CT scan or SPECT-CT scan) versus therapeutic (radiotherapy, tomotherapy, or dosimetric scanner)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful diagnostic or therapeutic examination</measure>
    <time_frame>1 hours after randomization</time_frame>
    <description>A patient will be considered a success if the planned immobilization period is completed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breakthrough Pain</condition>
  <arm_group>
    <arm_group_label>FAR Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl citrate</intervention_name>
    <description>Fentanyl citrate arm (FAR Arm): one intake of fentanyl citrate 100 µg (intranasal or buccal).&#xD;
Placebo Arm: one intake of placebo (intranasal or buccal) The administration route will be left to the discretion of the investigator taking into account the patient's profile (capable of maintaining the sublingual tablet without swallowing, absence of nasal discharge…), and/or the patient's choice.&#xD;
Medication Commercial name Formulation Administration route Dose Fentanyl citrate Pecfent® Nasal spray Intranasal 100 µg Fentanyl citrate Abstral® Sublingual tablet Buccal 100 µg For the cohort the choice of treatment by FAR is at the centres discretion, according to standard of practice.&#xD;
Treatment duration: 1 day</description>
    <arm_group_label>FAR Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>one intake of placebo (intranasal or buccal)</description>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years.&#xD;
&#xD;
          2. Patients in follow up or being treated for cancer.&#xD;
&#xD;
          3. Patients with cancer-related pain (area of pain located near primary tumor or&#xD;
             metastatic lesions).&#xD;
&#xD;
          4. Patients:&#xD;
&#xD;
               1. not having received any opioid treatment (opioid naïve).&#xD;
&#xD;
               2. or, treated for less than 7 days by a slow-releasing/extend-release opioid&#xD;
                  treatment; and/or by less than 60 mg per day of oral morphine, or less than 30&#xD;
                  mg/day of oral oxycodone, or less than 8 mg/day of oral hydromorphone, or less&#xD;
                  than 25 µg/h of transdermal fentanyl.&#xD;
&#xD;
          5. Patients need to have at least one of the following interventions, lasting between 25&#xD;
             and 45 minutes during which they will be request to not move:&#xD;
&#xD;
               1. Radiotherapy session*, including tomography (patients hospitalized or treated as&#xD;
                  outpatients).&#xD;
&#xD;
               2. Dosimetric scanner (hospitalized patients).&#xD;
&#xD;
               3. Positron-emission tomography** (PET): PET-computed tomography [CT] scan and&#xD;
                  single photon emission computed tomography [SPECT]-CT scan (hospitalized&#xD;
                  patients).&#xD;
&#xD;
          6. Public health insurance coverage.&#xD;
&#xD;
        (*) A patient who has numerous radiotherapy sessions can only be included once; (**) with&#xD;
        acquisition phase in a prostrate or decubitus dorsal position and strictly immobile in one&#xD;
        of the cameras (PET or SPECT).&#xD;
&#xD;
        Inclusion criteria (cohort):&#xD;
&#xD;
        As for the inclusion criteria for the phase II study, with the following modifications:&#xD;
&#xD;
        4. Patients treated with a slow-releasing/extended-release opioid for:&#xD;
&#xD;
          1. more than 7 days.&#xD;
&#xD;
          2. and with at least 60 mg per day of oral morphine, or at least 30 mg/day of oral&#xD;
             oxycodone, or at least 8 mg/day of oral hydromorphone, or at least 25 µg/h of&#xD;
             transdermal fentanyl.&#xD;
&#xD;
             5. Patients who believes that they are cannot assume a prostrate or decubitus dorsal&#xD;
             position for a diagnostic or therapeutic examination/intervention due to the pain they&#xD;
             will experienced in this position,&#xD;
&#xD;
             Or&#xD;
&#xD;
             Patients experience breakthrough pain (numerical pain scale 5), in a region&#xD;
             corresponding to the localization of the metastatic lesions or the primary tumor, when&#xD;
             they assume a prostrate/decubitus dorsal position,&#xD;
&#xD;
             Or&#xD;
&#xD;
             Patients who have breakthrough pain (numerical pain scale 5) in a region corresponding&#xD;
             to the localization of the metastatic lesions or the primary tumor that prevents the&#xD;
             completion of a diagnostic or therapeutic examination/intervention.&#xD;
&#xD;
             6. Public health insurance coverage.&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               1. Patients with contraindication for the administration of fentanyl citrate: severe&#xD;
                  respiratory depression or a severe obstructive pulmonary disease.&#xD;
&#xD;
               2. Patients who have already participated in this study.&#xD;
&#xD;
               3. Patients with a history of alcoholism or substance/drug dependence.&#xD;
&#xD;
               4. Patients with an intravenous or subcutaneous opioid patient-controlled analgesic&#xD;
                  (PCA) pump.&#xD;
&#xD;
               5. Patients unable to communicate or understand instructions in French.&#xD;
&#xD;
               6. Patients deprived of their liberty or under protective custody or guardianship,&#xD;
                  or unable to provide their consent for study participation.&#xD;
&#xD;
               7. Patients who are pregnant or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breakthrough Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breakthrough 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/NCT03809455
org study id: UC-0106/1607 SdS 02 FARADI
nct id: NCT03809455
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate
      is used outside of its marketing authorisation) Patients will be enrolled in an observational
      cohort when the fentanyl citrate is used according to its marketing authorisation.
Primary objective (phase II trial):

      Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain
      caused by positional requirements of a diagnostic or therapeutic intervention/examination in
      cancer patients who do not meet the prescription criteria for fentanyl citrate's marketing
      authorisation, as follows:

        -  Patients having received less than 60 mg of slow-release/extended-release morphine.

        -  Patients having received slow-release/extended-release morphine for less than 7 days.

        -  Patients who have not received any opioid treatment.

      Primary objective (cohort):

      Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain
      caused by positional requirements of a diagnostic or therapeutic intervention/examination in
      cancer patients when used within the marketing authorisation, as follows:

        -  Patients having at least 60 mg of slow-release/extended-release morphine.

        -  Patients having received slow-release/extended-release morphine for at least 7 days.

        -  Patients who have already received an opioid treatment (at least equivalent to 60 mg
           /day of oral morphine) for chronic cancer-related pain for at least 7 days.

      Secondary objectives (phase II and cohort):

        -  Evaluate the tolerance of the administration of fentanyl citrate when used to alleviate
           breakthrough pain caused by positional requirements of a diagnostic or therapeutic
           intervention/examination in cancer patients.

        -  Evaluate the efficacy of fentanyl citrate for reducing pain.

        -  Evaluate the efficacy of fentanyl citrate for reducing anxiety.

        -  Evaluate the percentage of relief and patients' satisfaction related to the
           administration of fentanyl citrate.

      Secondary objectives (phase II only):

      • Describe the reasons why the diagnostic or therapeutic intervention/examination failed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation.
The study will randomise patients (2:1; FAR Arm: Placebo Arm)
Stratified by:
Centre
Type of examination: diagnostic (PET-CT scan or SPECT-CT scan) versus therapeutic (radiotherapy, tomotherapy, or dosimetric scanner)
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Successful diagnostic or therapeutic examination
time frame: 1 hours after randomization
description: A patient will be considered a success if the planned immobilization period is completed.
arm group label: FAR Arm
arm group type: Experimental
arm group label: Placebo Arm
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Fentanyl citrate
description: Fentanyl citrate arm (FAR Arm): one intake of fentanyl citrate 100 µg (intranasal or buccal).
Placebo Arm: one intake of placebo (intranasal or buccal) The administration route will be left to the discretion of the investigator taking into account the patient's profile (capable of maintaining the sublingual tablet without swallowing, absence of nasal discharge…), and/or the patient's choice.
Medication Commercial name Formulation Administration route Dose Fentanyl citrate Pecfent® Nasal spray Intranasal 100 µg Fentanyl citrate Abstral® Sublingual tablet Buccal 100 µg For the cohort the choice of treatment by FAR is at the centres discretion, according to standard of practice.
Treatment duration: 1 day
arm group label: FAR Arm
intervention type: Drug
intervention name: Placebo
description: one intake of placebo (intranasal or buccal)
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Breakthrough Pain
mesh term: Fentanyl