<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/NCT02244320</url>
  </required_header>
  <id_info>
    <org_study_id>527.38</org_study_id>
    <nct_id>NCT02244320</nct_id>
  </id_info>
  <brief_title>Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)</brief_title>
  <official_title>Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of the observational study were to investigate the switch from phytotherapy to&#xD;
      ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of&#xD;
      ≥ 8 points (International Prostate Symptom Score (IPSS))&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2002</start_date>
  <primary_completion_date type="Actual">May 2003</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>Change in IPSS sum score</measure>
    <time_frame>Day 1, 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality-of-Life Index (QoL) rated on a 7-point scale</measure>
    <time_frame>Day 1, 2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sexual satisfaction rated on a 4-point scale</measure>
    <time_frame>Day 1, 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maximum urinary flow rate (ml/sec)</measure>
    <time_frame>Day 1, 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in residual urine volume (ml)</measure>
    <time_frame>Day 1, 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's global assessment of the preceding phytotherapy on a 3-point scale</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's global assessment of the therapy with ALNA® on a 3-point scale</measure>
    <time_frame>after 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale</measure>
    <time_frame>after 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale</measure>
    <time_frame>after 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse drug reactions (ADR)</measure>
    <time_frame>up to 2 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4150</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>functional BPH</arm_group_label>
    <description>patients with functional BPH who switched from phytotherapy to ALNA®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <arm_group_label>functional BPH</arm_group_label>
    <other_name>ALNA®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with functional BPH symptoms recruited at urologist offices&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from BPH symptoms&#xD;
&#xD;
          -  Preceding treatment with a phytotherapeutic for at least 4 weeks&#xD;
&#xD;
          -  IPSS sum score ≥ 8 points prior to treatment start with ALNA®&#xD;
&#xD;
          -  Indication for a switch to treatment with ALNA® for a minimum period of 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients fulfilling one of the general or specific contraindications listed in the&#xD;
             ALNA® Summary of Product Characteristic, particularly patients with known&#xD;
             hypersensitivities against tamsulosin hydrochloride or any other ingredient of the&#xD;
             product, orthostatic dysregulation or severe liver insufficiency&#xD;
&#xD;
          -  Patients receiving ALNA® within the 4 weeks prior to the start of the present&#xD;
             observational study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</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/NCT02244320
org study id: 527.38
nct id: NCT02244320
lead sponsor: 
The objective of the observational study were to investigate the switch from phytotherapy to
      ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of
      ≥ 8 points (International Prostate Symptom Score (IPSS))
observational model: Cohort
time perspective: Prospective
measure: Change in IPSS sum score
time frame: Day 1, 2 months
measure: Change in Quality-of-Life Index (QoL) rated on a 7-point scale
time frame: Day 1, 2 months
measure: Change in sexual satisfaction rated on a 4-point scale
time frame: Day 1, 2 months
measure: Change in maximum urinary flow rate (ml/sec)
time frame: Day 1, 2 months
measure: Change in residual urine volume (ml)
time frame: Day 1, 2 months
measure: Patient's global assessment of the preceding phytotherapy on a 3-point scale
time frame: Day 1
measure: Patient's global assessment of the therapy with ALNA® on a 3-point scale
time frame: after 2 months
measure: Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale
time frame: Day 1
measure: Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale
time frame: after 2 months
measure: Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale
time frame: Day 1
measure: Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale
time frame: after 2 months
measure: Number of patients with adverse drug reactions (ADR)
time frame: up to 2 months
arm group label: functional BPH
description: patients with functional BPH who switched from phytotherapy to ALNA®
intervention type: Drug
intervention name: Tamsulosin
arm group label: functional BPH
other name: ALNA®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tamsulosin