<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/NCT01726413</url>
  </required_header>
  <id_info>
    <org_study_id>GRC 17536-203</org_study_id>
    <secondary_id>2012-002320-33</secondary_id>
    <nct_id>NCT01726413</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).</brief_title>
  <official_title>A Phase II, 4-Week Randomised, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glenmark Pharmaceuticals Ltd. India</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glenmark Pharmaceuticals S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Glenmark Pharmaceuticals Ltd. India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent&#xD;
      injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,&#xD;
      and costs from a public health perspective. Painful diabetic neuropathy affects approximately&#xD;
      16% of patients with diabetes. Pharmacological agents used in the management of painful DPN&#xD;
      mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake&#xD;
      inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give&#xD;
      total relief, are not effective in all patients, and only about one-third of patients may&#xD;
      achieve more than 50% pain relief. Hence newer therapies are required for the treatment of&#xD;
      DPN. The primary outcome measures will be the change from baseline to end of treatment in the&#xD;
      mean 24-hour average pain intensity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean 24-hour average pain intensity (API) score.</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean night-time API Score</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Global Impression of Change</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Painful Diabetic Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Test Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GRC17356 for daily administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo for daily administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GRC 17356</intervention_name>
    <arm_group_label>Test Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients willing to provide voluntary written informed consent&#xD;
&#xD;
          2. Male and female patients ≥18 yrs and ≤75 yrs&#xD;
&#xD;
          3. Patients with diabetes mellitus with painful peripheral neuropathy for at least 6&#xD;
             months&#xD;
&#xD;
          4. A baseline 24-hour average daily pain intensity score ≥5&#xD;
&#xD;
          5. Women must be of non child-bearing potential, defined as post menopausal or surgically&#xD;
             sterile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other chronic pain conditions not associated with DPN, that may confound the&#xD;
             assessment of neuropathic pain&#xD;
&#xD;
          2. Other causes of neuropathy or lower extremity pain&#xD;
&#xD;
          3. Complex regional pain syndrome or trigeminal neuralgia&#xD;
&#xD;
          4. Lower extremity amputations other than toes&#xD;
&#xD;
          5. Participation in another study with an investigational compound within the previous 90&#xD;
             days prior to study medication administration, or concurrent participation in another&#xD;
             clinical study&#xD;
&#xD;
          6. Major depression.&#xD;
&#xD;
          7. Presence or history of cancer within the past 5 years with the exception of adequately&#xD;
             treated localized basal cell skin cancer or in situ uterine cervical cancer.&#xD;
&#xD;
          8. Patients with clinically significant or uncontrolled hepatic, gastrointestinal,&#xD;
             cardiovascular, respiratory, neurological (other than neuropathy), psychiatric,&#xD;
             hematological, renal, or dermatological disease, or any other medical condition that&#xD;
             according to Investigator's medical judgment: Could interfere with the accurate&#xD;
             assessment of safety or efficacy, or, Could potentially affect a patient's safety or&#xD;
             study outcome&#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>Dr. Balamurugan Ramanathan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kovai Diabetes Speciality Centre and Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Vijay Viswanathan</last_name>
    <role>Principal Investigator</role>
    <affiliation>MV Hospital for Diabetes (P) Ltd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Mallikarjun V Jali</last_name>
    <role>Principal Investigator</role>
    <affiliation>K.L.E.S Dr. Prabhakar Kore Hospital &amp; Medical research Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Sunil M Jain</last_name>
    <role>Principal Investigator</role>
    <affiliation>TOTALL Diabetes Hormone Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Dinesh Dhanwal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maulana Azad Medical College &amp; Associate Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. S Srikanta</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jnana Sanjeevani Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Jayashri Shembalkar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Getwell Hospital and Research Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Peter Dewland</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICON Manchester CPU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Prof Thomas Forst</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Paramesh Shammana</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bangalore Clinisearch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Arthur Asirvatham</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arthur Asirvathma Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Mohan Magdum</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jehangir Clinical Development Centre Pvt. Ltd.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Blanka Lubenova</last_name>
    <role>Principal Investigator</role>
    <affiliation>NeuroHelp s.r.o</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. David Dolezil</last_name>
    <role>Principal Investigator</role>
    <affiliation>DADO Medical s.r.o</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NeuroHelp s.r.o</name>
      <address>
        <city>Olomouc</city>
        <state>Prague</state>
        <zip>772 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DADO Medical s.r.o</name>
      <address>
        <city>Prague</city>
        <zip>12000</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DADO Medical s.r.o</name>
      <address>
        <city>Ricany</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bangalore Clinisearch</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560043</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K.L.E.S Dr. Prabhakar Kore Hospital &amp; Medical research Centre</name>
      <address>
        <city>Belgaum</city>
        <state>Karnataka</state>
        <zip>590010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jnana Sanjeevani Medical Centre</name>
      <address>
        <city>Bangalore</city>
        <state>Karntaka</state>
        <zip>560078</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TOTALL Diabetes Hormone Institute</name>
      <address>
        <city>Indore</city>
        <state>Madhya Pradesh</state>
        <zip>452010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jehangir Clinical development Centre Pvt Ltd</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Getwell Hospital and Research Centre</name>
      <address>
        <city>Nagpur</city>
        <state>Maharastra</state>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MV Hospital for Diabetes (P) Ltd</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600 013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kovai Diabetes Speciality Centre and Hospital</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641 009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthur Asirvathma Hospital</name>
      <address>
        <city>Madhurai</city>
        <state>Tamil Nadu</state>
        <zip>625020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maulana Azad Medical College &amp; Associate Hospitals</name>
      <address>
        <city>New Delhi</city>
        <zip>110002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICON Manchester CPU</name>
      <address>
        <city>Manchester</city>
        <state>UK</state>
        <zip>M15 6SH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>India</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
    <mesh_term>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/NCT01726413
org study id: GRC 17536-203
secondary id: 2012-002320-33
nct id: NCT01726413
lead sponsor: 
collaborator: 
has dmc: No
Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent
      injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,
      and costs from a public health perspective. Painful diabetic neuropathy affects approximately
      16% of patients with diabetes. Pharmacological agents used in the management of painful DPN
      mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake
      inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give
      total relief, are not effective in all patients, and only about one-third of patients may
      achieve more than 50% pain relief. Hence newer therapies are required for the treatment of
      DPN. The primary outcome measures will be the change from baseline to end of treatment in the
      mean 24-hour average pain intensity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean 24-hour average pain intensity (API) score.
time frame: Week 4
measure: Mean night-time API Score
time frame: 4 weeks
measure: Patient Global Impression of Change
time frame: 4 weeks
measure: Clinician Global Impression of Change
time frame: 4 weeks
arm group label: Test Arm
arm group type: Experimental
description: GRC17356 for daily administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo for daily administration
intervention type: Drug
intervention name: GRC 17356
arm group label: Test Arm
intervention type: Drug
intervention name: Matching Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dr. Balamurugan Ramanathan
role: Principal Investigator
affiliation: Kovai Diabetes Speciality Centre and Hospital
last name: Dr. Vijay Viswanathan
role: Principal Investigator
affiliation: MV Hospital for Diabetes (P) Ltd
last name: Dr. Mallikarjun V Jali
role: Principal Investigator
affiliation: K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
last name: Dr. Sunil M Jain
role: Principal Investigator
affiliation: TOTALL Diabetes Hormone Institute
last name: Dr. Dinesh Dhanwal
role: Principal Investigator
affiliation: Maulana Azad Medical College & Associate Hospitals
last name: Dr. S Srikanta
role: Principal Investigator
affiliation: Jnana Sanjeevani Medical Centre
last name: Dr. Jayashri Shembalkar
role: Principal Investigator
affiliation: Getwell Hospital and Research Centre
last name: Dr Peter Dewland
role: Principal Investigator
affiliation: ICON Manchester CPU
last name: Dr. Prof Thomas Forst
role: Principal Investigator
affiliation: Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
last name: Dr. Paramesh Shammana
role: Principal Investigator
affiliation: Bangalore Clinisearch
last name: Dr. Arthur Asirvatham
role: Principal Investigator
affiliation: Arthur Asirvathma Hospital
last name: Dr. Mohan Magdum
role: Principal Investigator
affiliation: Jehangir Clinical Development Centre Pvt. Ltd.
last name: Dr. Blanka Lubenova
role: Principal Investigator
affiliation: NeuroHelp s.r.o
last name: Dr. David Dolezil
role: Principal Investigator
affiliation: DADO Medical s.r.o
facility: 
facility: 
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facility: 
facility: 
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country: Czech Republic
country: Germany
country: India
country: United Kingdom
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
mesh term: Pain