<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/NCT02223442</url>
  </required_header>
  <id_info>
    <org_study_id>opioids for chronic pain</org_study_id>
    <nct_id>NCT02223442</nct_id>
  </id_info>
  <brief_title>Central Analgesic Drugs for the Treatment of Chronic Pain</brief_title>
  <official_title>Cognitive Study on the Use of Central Analgesic Drugs in the Management of Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Parma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain is defined as pain that persists after healing of the wound that caused it, and&#xD;
      can occur even in the absence of any obvious pathological trigger. In our country, there is a&#xD;
      growing interest in the proper management of the disease &quot;pain&quot;.&#xD;
&#xD;
      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease&#xD;
      and from 75% to 90% of patients with advanced cancer suffers from chronic pain .&#xD;
&#xD;
      However, pain management is mostly inadequate. This study aims to assess the Italian clinical&#xD;
      practice in reference to the pharmacological management of chronic pain by health&#xD;
      professionals involved in the treatment of pain in some centers belonging to the Italian&#xD;
      network of pain therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain is defined as pain that persists after healing of the wound that caused it, and&#xD;
      can occur even in the absence of any obvious pathological trigger. In our country, there is a&#xD;
      growing interest in the proper management of the disease &quot;pain&quot;.&#xD;
&#xD;
      In fact, the Ministry of Health, first in Europe, introduced a law in 2010 (March 15, 2010,&#xD;
      No. 38) to provide for the sick, cancer or not, easy access to the necessary care and to&#xD;
      provide specialists a specific training course.&#xD;
&#xD;
      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease&#xD;
      and from 75% to 90% of patients with advanced cancer suffers from chronic pain (Marcus 2011).&#xD;
&#xD;
      The &quot;pain disease&quot; is one of the most common causes of access to medical care so it should be&#xD;
      recognized as a complex health and research problem, being one of the most expensive and&#xD;
      investigated conditions in our society (Pizzo and Clark, 2012; Gupta et al. , 2010; Dagenais&#xD;
      et al., 2008).&#xD;
&#xD;
      It has a significant impact on the subjective perception of health status, influence daily&#xD;
      activities and is associated with symptoms of depression and other psychological problems&#xD;
      that affect the quality of life of the patient (end of 2011 Gureje et al., 1998; Bair et al.,&#xD;
      2003, Portenoy, 1996).&#xD;
&#xD;
      However, pain management is mostly inadequate for several medical and social reasons:&#xD;
      difficulty in defining the complexity of its pathophysiology, difficulty in finding animal&#xD;
      models useful for the development of analgesic drugs, difficulty in finding clinical models&#xD;
      predictive of drug efficacy / security, lack of recognition of pain as a health issue and not&#xD;
      adequate academic training.&#xD;
&#xD;
      A recent survey in Europe uncovered alarming data: 40% of surveyed patients (46,394) reported&#xD;
      an inadequate treatment of accused pain (Breivik et al., 2006).&#xD;
&#xD;
      There are also several open questions regarding the research on the most powerful analgesic&#xD;
      drugs used: opioids (Galer et al 1992).&#xD;
&#xD;
      There is no specific experimental model able to solve the three most pressing problems: the&#xD;
      predictability of the patient's response, efficacy and safety of opioids.&#xD;
&#xD;
      There is no scientific evidence for the efficacy / safety of long-term use of opioids in&#xD;
      chronic pain (Chapman et al., 2010; Manchikanti et al., 2011).&#xD;
&#xD;
      A recent review showed that approximately 22% of patients, suffering from chronic pain and on&#xD;
      opioid therapy, suspends therapy for the occurrence of side effects and 5-10% of patients&#xD;
      suspend it for a not proper control of pain symptoms (Noble et al., 2010).&#xD;
&#xD;
      This study aims to assess the Italian clinical practice in reference to the pharmacological&#xD;
      management of chronic pain by health professionals involved in the treatment of pain in some&#xD;
      centers belonging to the Italian network of pain therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2016</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>adherence to therapy</measure>
    <time_frame>18 months</time_frame>
    <description>to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adherence at 6 months</measure>
    <time_frame>18 months</time_frame>
    <description>differences between the central analgesic drugs in the percentage of patients who continue therapy (adherence) at 1 month and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>18 months</time_frame>
    <description>difference between the central analgesic drugs in the percentage of patients who develop side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>18 months</time_frame>
    <description>difference between the central analgesic drugs with regard to the improvement of quality of life reported by the patient</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Chronic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with persistent pain syndromes (chronic pain) followed on an outpatient / DH at&#xD;
        some Italian centers of Pain Therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females over the age of 18 years&#xD;
&#xD;
          -  Chronic neuropathic and / or nociceptive and / or mixed pain, whereby clinicians&#xD;
             considers necessary to start opioid therapy&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males and females aged under 18 years&#xD;
&#xD;
          -  Patients already receiving opioid analgesic drugs or drugs of the class MOR-NRI.&#xD;
&#xD;
          -  Taking abuse drugs or alcohol abuse&#xD;
&#xD;
          -  Patients with contraindications to the use of central analgesic drugs&#xD;
&#xD;
          -  Patients who refuse participation&#xD;
&#xD;
          -  Prior cognitive impairment or mental retardation&#xD;
&#xD;
          -  Severe immunodeficiency (WBC &lt;4,000)&#xD;
&#xD;
          -  Severe renal impairment (serum creatinine &gt; 2g/dl or Creatinine clearance &lt;30 ml / h)&#xD;
&#xD;
          -  Hepatic impairment (Cholinesterase &lt;2.000UI or INR&gt; 2)&#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_official>
    <last_name>Christian Compagnone</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Compagnone</last_name>
    <phone>0521-703567</phone>
    <email>ccompagnone@parmanesthesia.com</email>
  </overall_contact>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Christian Compagnone</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>chronic pain</keyword>
  <keyword>central analgesic drugs</keyword>
  <keyword>adherence to therapy</keyword>
  <keyword>side effects</keyword>
  <keyword>quality of life</keyword>
  <keyword>MOR-NRI drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02223442
org study id: opioids for chronic pain
nct id: NCT02223442
lead sponsor: 
has dmc: No
Chronic pain is defined as pain that persists after healing of the wound that caused it, and
      can occur even in the absence of any obvious pathological trigger. In our country, there is a
      growing interest in the proper management of the disease "pain".

      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease
      and from 75% to 90% of patients with advanced cancer suffers from chronic pain .

      However, pain management is mostly inadequate. This study aims to assess the Italian clinical
      practice in reference to the pharmacological management of chronic pain by health
      professionals involved in the treatment of pain in some centers belonging to the Italian
      network of pain therapy.
Chronic pain is defined as pain that persists after healing of the wound that caused it, and
      can occur even in the absence of any obvious pathological trigger. In our country, there is a
      growing interest in the proper management of the disease "pain".

      In fact, the Ministry of Health, first in Europe, introduced a law in 2010 (March 15, 2010,
      No. 38) to provide for the sick, cancer or not, easy access to the necessary care and to
      provide specialists a specific training course.

      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease
      and from 75% to 90% of patients with advanced cancer suffers from chronic pain (Marcus 2011).

      The "pain disease" is one of the most common causes of access to medical care so it should be
      recognized as a complex health and research problem, being one of the most expensive and
      investigated conditions in our society (Pizzo and Clark, 2012; Gupta et al. , 2010; Dagenais
      et al., 2008).

      It has a significant impact on the subjective perception of health status, influence daily
      activities and is associated with symptoms of depression and other psychological problems
      that affect the quality of life of the patient (end of 2011 Gureje et al., 1998; Bair et al.,
      2003, Portenoy, 1996).

      However, pain management is mostly inadequate for several medical and social reasons:
      difficulty in defining the complexity of its pathophysiology, difficulty in finding animal
      models useful for the development of analgesic drugs, difficulty in finding clinical models
      predictive of drug efficacy / security, lack of recognition of pain as a health issue and not
      adequate academic training.

      A recent survey in Europe uncovered alarming data: 40% of surveyed patients (46,394) reported
      an inadequate treatment of accused pain (Breivik et al., 2006).

      There are also several open questions regarding the research on the most powerful analgesic
      drugs used: opioids (Galer et al 1992).

      There is no specific experimental model able to solve the three most pressing problems: the
      predictability of the patient's response, efficacy and safety of opioids.

      There is no scientific evidence for the efficacy / safety of long-term use of opioids in
      chronic pain (Chapman et al., 2010; Manchikanti et al., 2011).

      A recent review showed that approximately 22% of patients, suffering from chronic pain and on
      opioid therapy, suspends therapy for the occurrence of side effects and 5-10% of patients
      suspend it for a not proper control of pain symptoms (Noble et al., 2010).

      This study aims to assess the Italian clinical practice in reference to the pharmacological
      management of chronic pain by health professionals involved in the treatment of pain in some
      centers belonging to the Italian network of pain therapy.
observational model: Cohort
time perspective: Prospective
measure: adherence to therapy
time frame: 18 months
description: to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment
measure: adherence at 6 months
time frame: 18 months
description: differences between the central analgesic drugs in the percentage of patients who continue therapy (adherence) at 1 month and 6 months
measure: side effects
time frame: 18 months
description: difference between the central analgesic drugs in the percentage of patients who develop side effects
measure: quality of life
time frame: 18 months
description: difference between the central analgesic drugs with regard to the improvement of quality of life reported by the patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Compagnone
role: Principal Investigator
affiliation: University of Parma
last name: Christian Compagnone
phone: 0521-703567
email: ccompagnone@parmanesthesia.com
responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Christian Compagnone
investigator title: MD
mesh term: Chronic Pain