<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/NCT02232256</url>
  </required_header>
  <id_info>
    <org_study_id>CALPXT96-01</org_study_id>
    <nct_id>NCT02232256</nct_id>
  </id_info>
  <brief_title>The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain</brief_title>
  <acronym>CALPXT96</acronym>
  <official_title>A Phase 3 Double Blind, Randomized, Placebo Controlled, Cross-Over Trial to Asses the Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>9305-9954 Quebec Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>9305-9954 Quebec Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild&#xD;
      sedative and/or sleep aid. However there are no human clinical trial data to support its use.&#xD;
      Sleep disturbances are a well-recognized component of chronic pain, and lead to additional&#xD;
      social withdrawal, greater pain and worsening depression. Most hypnotics available either&#xD;
      place the patient at further risk (e.g. benzodiazepines combined with opioids increase the&#xD;
      risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime&#xD;
      somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in&#xD;
      Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid&#xD;
      adverse effects while improving sleep. An open-label clinical trial was performed to obtain&#xD;
      preliminary safety and efficacy information of California poppy. This trial was approved by a&#xD;
      central ethics review board. The study results showed that California poppy, can be used as a&#xD;
      co-analgesic to provide additional analgesia and/or sleep improvement to the patient.&#xD;
      Patients who are referred to the clinic will be asked to complete a few short questionnaires&#xD;
      at every visit and on monthly basis respectively. This data, in addition to the usual&#xD;
      follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain&#xD;
      Disability Index, Short-form Health Survey-12v2) and general demographic and medical&#xD;
      information will be used to assess California Poppy's effectiveness on patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
&#xD;
      This will be an 'n of 1' model, with the patient acting as their own control. To identify any&#xD;
      possible negative 'wash out' effect after cessation of the active medication (that could&#xD;
      negatively impact the 'no drug' arm) we have to do the following. After baseline&#xD;
      documentation with standardized scales, randomize to one of 2 arms:&#xD;
&#xD;
        1. Arm A&#xD;
&#xD;
             -  1st treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)&#xD;
&#xD;
             -  2 week wash out period&#xD;
&#xD;
             -  2nd treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)&#xD;
&#xD;
        2. Arm B&#xD;
&#xD;
             -  1st treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)&#xD;
&#xD;
             -  2 week ash out period&#xD;
&#xD;
             -  -2nd treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary objective&#xD;
&#xD;
      The primary objective of this study is:&#xD;
&#xD;
        -  Does nightly use of CALPXT96 improve sleep in patients with CNCP? Secondary objective&#xD;
&#xD;
        -  The secondary objective of this study are:&#xD;
&#xD;
        -  Does CALPXT96 improve functionality as defined by the PDI (or Short-Form Health&#xD;
           Survey-12 (SF12))?&#xD;
&#xD;
        -  Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?&#xD;
&#xD;
        -  Does CALPXT96 allow for a decrease in other medications prescribed for pain?&#xD;
&#xD;
      Efficacy Measures&#xD;
&#xD;
        -  Changes in quality of seep as measured by the the Pittsburgh Sleep Quality Index (PSQI)&#xD;
           and the Pain and Sleep Questionnaire (PSQ-3).&#xD;
&#xD;
        -  Changes in pain intensity scores (Brief Pain Inventory) and changes in functionality and&#xD;
           health related quality of life as measured with the Pain Disability Index (PDI) and&#xD;
           SF-12v2 respectively.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      Chronic pain patients suffering from CNCP for greater than 1 year, with complaint of poor&#xD;
      sleep (defined as &gt;/= 5 on the Pittsburgh Sleep Quality Index (PSQI), aged 18 and up and of a&#xD;
      normal mix of gender, age, and socioeconomic status and with a stable pain management&#xD;
      treatment for at least one month.&#xD;
&#xD;
      Inclusion Criteria&#xD;
&#xD;
      Subjects are eligible to be included in the study only if they meet all of the following&#xD;
      criteria:&#xD;
&#xD;
        1. Age &gt; 17 and &lt; 75&#xD;
&#xD;
        2. Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. (Validated&#xD;
           tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a&#xD;
           suitable cut points (PSQI &gt;/=5) to ensure greater homogeneity of the sample and the&#xD;
           recruitment of only those with significant pain related sleep disturbance.)&#xD;
&#xD;
        3. Stable pain management therapy for 1 month prior to entry into the study&#xD;
&#xD;
        4. Having a confirmed diagnosis of CNCP for greater than 1 year&#xD;
&#xD;
        5. Written informed consent obtained.&#xD;
&#xD;
        6. Subject agreed to follow the protocol.&#xD;
&#xD;
      Exclusion Criteria&#xD;
&#xD;
      Subjects will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
        1. Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they are&#xD;
           willing to cease any current hypnotic for at least 2 weeks prior to commencing the study&#xD;
&#xD;
        2. Current alcohol abuse or other addiction&#xD;
&#xD;
        3. Sleep apnea disorder&#xD;
&#xD;
        4. Inability to understand and comply with the instructions of the study&#xD;
&#xD;
        5. Previous enrollment in the study&#xD;
&#xD;
        6. Renal and/or liver insufficiency&#xD;
&#xD;
        7. Patients less than age 18&#xD;
&#xD;
        8. Pregnancy or lactation&#xD;
&#xD;
        9. Current (&lt;/=one year) Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnosis of&#xD;
           major depressive disorder, dysthymia, generalized anxiety disorder and DSM-IV diagnosis&#xD;
           of mania, bipolar disorder, or psychosis determined either by patient history&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Site unable to enrol recruited subjects&#xD;
  </why_stopped>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Does nightly use of CALPXT96 improve sleep in patients with CNCP?</measure>
    <time_frame>Change from Baseline in PSQI at Days 30, 44 and 74.</time_frame>
    <description>Changes in quality of sleep as measured by the the Pittsburgh Sleep Quality Index (PSQI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Does nightly use of CALPXT96 improve sleep in patients with CNCP?</measure>
    <time_frame>Change from Baseline in PSQ-3 at Days 15, 30, 44, 59 and 74.</time_frame>
    <description>Changes in quality of sleep as measured by the Pain and Sleep Questionnaire (PSQ-3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Does CALPXT96 improve functionality as defined by the PDI (or SF12)?</measure>
    <time_frame>Change from Baseline in PDI (or SF12) at Days 15, 30, 44, 59 and 74.</time_frame>
    <description>Changes in functionality and health related quality of life as measured with the Pain Disability Index (or SF-12v2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?</measure>
    <time_frame>Change from Baseline in BPI at Days 15, 30, 44, 59 and 74.</time_frame>
    <description>Changes in pain intensity scores (Brief Pain Inventory).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does CALPXT96 allow for a decrease in other medications prescribed for pain?</measure>
    <time_frame>Change from Baseline at Days 15, 30, 44, 59 and 74.</time_frame>
    <description>Concomitant and rescue medication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>CALPXT96</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)&#xD;
2 week wash out period&#xD;
2nd treatment period: 4 weeks placebo (two capsules hs at bedtime)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1st treatment period: 4 weeks placebo (two capsules hs at bedtime)&#xD;
2 week wash 'out' period&#xD;
2nd treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CALPXT96</intervention_name>
    <description>Arm 1: intervention begins with CALPXT96 Arm 2: intervention begins with placebo</description>
    <arm_group_label>CALPXT96</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>California poppy standardized extract</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 17 and &lt; 75&#xD;
&#xD;
          -  Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. Validated&#xD;
             tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a&#xD;
             suitable cut points (PSQI &gt;/=5) to ensure greater homogeneity of the sample and the&#xD;
             recruitment of only those with significant pain related sleep disturbance.&#xD;
&#xD;
          -  Stable pain management therapy for 1 month prior to entry into the study&#xD;
&#xD;
          -  Having a confirmed diagnosis of CNCP for greater than 1 year&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
          -  Subject agreed to follow the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they&#xD;
             are willing to cease any current hypnotic for at least 2 weeks prior to commencing the&#xD;
             study&#xD;
&#xD;
          -  Current alcohol abuse or other addiction&#xD;
&#xD;
          -  Sleep apnea disorder&#xD;
&#xD;
          -  Inability to understand and comply with the instructions of the study&#xD;
&#xD;
          -  Previous enrollment in the study&#xD;
&#xD;
          -  Renal and/or liver insufficiency&#xD;
&#xD;
          -  Patients less than age 18&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Current (&lt;/=one year) DSM-IV Axis I diagnosis of major depressive disorder, dysthymia,&#xD;
             generalized anxiety disorder and DSM-IV diagnosis of mania, bipolar disorder, or&#xD;
             psychosis determined either by patient history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Ducharme, MD CM</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CPM - Centres for Pain Managemen</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5N 3E7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic non-cancer pain</keyword>
  <keyword>Insomnia</keyword>
  <keyword>California poppy</keyword>
  <keyword>Eschscholzia californica</keyword>
  <keyword>Pain</keyword>
  <keyword>Sleep quality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_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/NCT02232256
org study id: CALPXT96-01
nct id: NCT02232256
lead sponsor: 
collaborator: 
has dmc: No
California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild
      sedative and/or sleep aid. However there are no human clinical trial data to support its use.
      Sleep disturbances are a well-recognized component of chronic pain, and lead to additional
      social withdrawal, greater pain and worsening depression. Most hypnotics available either
      place the patient at further risk (e.g. benzodiazepines combined with opioids increase the
      risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime
      somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in
      Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid
      adverse effects while improving sleep. An open-label clinical trial was performed to obtain
      preliminary safety and efficacy information of California poppy. This trial was approved by a
      central ethics review board. The study results showed that California poppy, can be used as a
      co-analgesic to provide additional analgesia and/or sleep improvement to the patient.
      Patients who are referred to the clinic will be asked to complete a few short questionnaires
      at every visit and on monthly basis respectively. This data, in addition to the usual
      follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain
      Disability Index, Short-form Health Survey-12v2) and general demographic and medical
      information will be used to assess California Poppy's effectiveness on patients
Study Design:

      This will be an 'n of 1' model, with the patient acting as their own control. To identify any
      possible negative 'wash out' effect after cessation of the active medication (that could
      negatively impact the 'no drug' arm) we have to do the following. After baseline
      documentation with standardized scales, randomize to one of 2 arms:

        1. Arm A

             -  1st treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)

             -  2 week wash out period

             -  2nd treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)

        2. Arm B

             -  1st treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)

             -  2 week ash out period

             -  -2nd treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)

      Objectives:

      Primary objective

      The primary objective of this study is:

        -  Does nightly use of CALPXT96 improve sleep in patients with CNCP? Secondary objective

        -  The secondary objective of this study are:

        -  Does CALPXT96 improve functionality as defined by the PDI (or Short-Form Health
           Survey-12 (SF12))?

        -  Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?

        -  Does CALPXT96 allow for a decrease in other medications prescribed for pain?

      Efficacy Measures

        -  Changes in quality of seep as measured by the the Pittsburgh Sleep Quality Index (PSQI)
           and the Pain and Sleep Questionnaire (PSQ-3).

        -  Changes in pain intensity scores (Brief Pain Inventory) and changes in functionality and
           health related quality of life as measured with the Pain Disability Index (PDI) and
           SF-12v2 respectively.

      Population:

      Chronic pain patients suffering from CNCP for greater than 1 year, with complaint of poor
      sleep (defined as >/= 5 on the Pittsburgh Sleep Quality Index (PSQI), aged 18 and up and of a
      normal mix of gender, age, and socioeconomic status and with a stable pain management
      treatment for at least one month.

      Inclusion Criteria

      Subjects are eligible to be included in the study only if they meet all of the following
      criteria:

        1. Age > 17 and < 75

        2. Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. (Validated
           tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a
           suitable cut points (PSQI >/=5) to ensure greater homogeneity of the sample and the
           recruitment of only those with significant pain related sleep disturbance.)

        3. Stable pain management therapy for 1 month prior to entry into the study

        4. Having a confirmed diagnosis of CNCP for greater than 1 year

        5. Written informed consent obtained.

        6. Subject agreed to follow the protocol.

      Exclusion Criteria

      Subjects will be excluded from the study if they meet any of the following criteria:

        1. Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they are
           willing to cease any current hypnotic for at least 2 weeks prior to commencing the study

        2. Current alcohol abuse or other addiction

        3. Sleep apnea disorder

        4. Inability to understand and comply with the instructions of the study

        5. Previous enrollment in the study

        6. Renal and/or liver insufficiency

        7. Patients less than age 18

        8. Pregnancy or lactation

        9. Current (</=one year) Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnosis of
           major depressive disorder, dysthymia, generalized anxiety disorder and DSM-IV diagnosis
           of mania, bipolar disorder, or psychosis determined either by patient history
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Does nightly use of CALPXT96 improve sleep in patients with CNCP?
time frame: Change from Baseline in PSQI at Days 30, 44 and 74.
description: Changes in quality of sleep as measured by the the Pittsburgh Sleep Quality Index (PSQI).
measure: Does nightly use of CALPXT96 improve sleep in patients with CNCP?
time frame: Change from Baseline in PSQ-3 at Days 15, 30, 44, 59 and 74.
description: Changes in quality of sleep as measured by the Pain and Sleep Questionnaire (PSQ-3).
measure: Does CALPXT96 improve functionality as defined by the PDI (or SF12)?
time frame: Change from Baseline in PDI (or SF12) at Days 15, 30, 44, 59 and 74.
description: Changes in functionality and health related quality of life as measured with the Pain Disability Index (or SF-12v2).
measure: Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?
time frame: Change from Baseline in BPI at Days 15, 30, 44, 59 and 74.
description: Changes in pain intensity scores (Brief Pain Inventory).
measure: Does CALPXT96 allow for a decrease in other medications prescribed for pain?
time frame: Change from Baseline at Days 15, 30, 44, 59 and 74.
description: Concomitant and rescue medication
arm group label: CALPXT96
arm group type: Experimental
description: 1st treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)
2 week wash out period
2nd treatment period: 4 weeks placebo (two capsules hs at bedtime)
arm group label: Placebo
arm group type: Placebo Comparator
description: 1st treatment period: 4 weeks placebo (two capsules hs at bedtime)
2 week wash 'out' period
2nd treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)
intervention type: Drug
intervention name: CALPXT96
description: Arm 1: intervention begins with CALPXT96 Arm 2: intervention begins with placebo
arm group label: CALPXT96
arm group label: Placebo
other name: California poppy standardized extract
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: James Ducharme, MD CM
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Chronic Pain