<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/NCT02977832</url>
  </required_header>
  <id_info>
    <org_study_id>IRCCSPSM</org_study_id>
    <nct_id>NCT02977832</nct_id>
  </id_info>
  <brief_title>Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia</brief_title>
  <acronym>Odyliresin</acronym>
  <official_title>A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Matteo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Matteo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action&#xD;
      on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume,&#xD;
      improving the patient's quality of life and eventually limiting the number of patients who&#xD;
      require surgery or endoscopy after medical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique&#xD;
      chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms,&#xD;
      prostate volume, improve the patient's quality of life and eventually to limit number of&#xD;
      patients who require surgery or endoscopy after medical treatment. To this aim, patients who&#xD;
      seek specialist advice for LUTS with no previous surgical treatment for BPH have been&#xD;
      selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine&#xD;
      whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are&#xD;
      significantly improved, and a reduction of prostatic volume can be observed, thus changing&#xD;
      the usual course of the disease. All patients with BPH-related LUTS received both alphalitic&#xD;
      and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly&#xD;
      improved, adenoma volume and post-void residual volume were significantly reduced at 12&#xD;
      month. This is the first clinical experience with Iresine Celosia in BPH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Prostate Symptom Score</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum flow rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average flow rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenoma volume</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual urine volume</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Benign Prostatic Hypertrophy With Outflow Obstruction</condition>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>odyliresin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Odyliresin (Iresine celosia) 2 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>alphalytic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>alpha-antagonist (alfuzosin 10 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Odyliresin</intervention_name>
    <description>Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)</description>
    <arm_group_label>alphalytic</arm_group_label>
    <arm_group_label>odyliresin</arm_group_label>
    <other_name>Iresine Celosia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alfuzosin</intervention_name>
    <description>10Mg Oral Tablet, Extended Release</description>
    <arm_group_label>alphalytic</arm_group_label>
    <arm_group_label>odyliresin</arm_group_label>
    <other_name>alphalytic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  45 years of age or older&#xD;
&#xD;
          -  Clinically diagnosed with mild to moderate BPH&#xD;
&#xD;
          -  Prostatic volume ≥ 30 ml determined by transrectal ultrasound&#xD;
&#xD;
          -  Maximum flow rate (Qmax) &lt; 15 ml/sec for a voided volume 150-500 ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have severe BPH (IPSS symptom score &gt;21)&#xD;
&#xD;
          -  Participants should not be currently undergoing any other form of medical therapy for&#xD;
             BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E,&#xD;
             and quercetin).&#xD;
&#xD;
          -  Patients must not have undergone prior transurethral resection of the prostate (TURP).&#xD;
&#xD;
          -  Post void residual (PVD) &gt; 200 ml&#xD;
&#xD;
          -  Previous urological history including urethral stricture disease and/or bladder neck&#xD;
             disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer,&#xD;
             interstitial cystitis, active upper tract stone disease causing symptoms,&#xD;
             insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes&#xD;
             mellitus, chronic renal failure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmine Tinelli, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ethics Committee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Department Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.</citation>
    <PMID>18533373</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>February 26, 2017</last_update_submitted>
  <last_update_submitted_qc>February 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Matteo</investigator_affiliation>
    <investigator_full_name>Daniele Porru</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>LUTS</keyword>
  <keyword>Iresine celosia</keyword>
  <keyword>Odyliresin</keyword>
  <keyword>medical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alfuzosin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02977832
org study id: IRCCSPSM
nct id: NCT02977832
lead sponsor: 
has dmc: Yes
Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action
      on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume,
      improving the patient's quality of life and eventually limiting the number of patients who
      require surgery or endoscopy after medical treatment.
The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique
      chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms,
      prostate volume, improve the patient's quality of life and eventually to limit number of
      patients who require surgery or endoscopy after medical treatment. To this aim, patients who
      seek specialist advice for LUTS with no previous surgical treatment for BPH have been
      selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine
      whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are
      significantly improved, and a reduction of prostatic volume can be observed, thus changing
      the usual course of the disease. All patients with BPH-related LUTS received both alphalitic
      and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly
      improved, adenoma volume and post-void residual volume were significantly reduced at 12
      month. This is the first clinical experience with Iresine Celosia in BPH.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
primary purpose: Treatment
masking: None (Open Label)
measure: International Prostate Symptom Score
time frame: 12 months
measure: Maximum flow rate
time frame: 12 months
measure: Average flow rate
time frame: 12 months
measure: Adenoma volume
time frame: 12 months
measure: Residual urine volume
time frame: 12 months
measure: adverse events
time frame: 12 months
measure: Quality of life score
time frame: 12 months
arm group label: odyliresin
arm group type: Experimental
description: Odyliresin (Iresine celosia) 2 ml
arm group label: alphalytic
arm group type: Experimental
description: alpha-antagonist (alfuzosin 10 mg)
intervention type: Dietary Supplement
intervention name: Odyliresin
description: Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
arm group label: alphalytic
arm group label: odyliresin
other name: Iresine Celosia
intervention type: Drug
intervention name: Alfuzosin
description: 10Mg Oral Tablet, Extended Release
arm group label: alphalytic
arm group label: odyliresin
other name: alphalytic
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carmine Tinelli, MD
role: Study Chair
affiliation: Ethics Committee
facility: 
country: Italy
citation: Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.
PMID: 18533373
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Matteo
investigator full name: Daniele Porru
investigator title: MD
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Hypertrophy
mesh term: Alfuzosin
sharing ipd: Undecided