<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/NCT01684800</url>
  </required_header>
  <id_info>
    <org_study_id>000029</org_study_id>
    <nct_id>NCT01684800</nct_id>
  </id_info>
  <brief_title>Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Women</brief_title>
  <acronym>NOC</acronym>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the efficacy and safety of two different dose&#xD;
      levels of desmopressin orally disintegrating tablets against placebo for the treatment of&#xD;
      nocturia in adult women during 12 weeks treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Change from baseline in mean number of nocturnal voids</measure>
    <time_frame>During 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean time to first void</measure>
    <time_frame>During 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder status (33% reduction in nocturnal voids)</measure>
    <time_frame>During 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean number of nocturnal voids</measure>
    <time_frame>1, 4, 8 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean time to first void</measure>
    <time_frame>1, 4, 8 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder status (33% reduction in nocturnal voids)</measure>
    <time_frame>1, 4, 8 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean nocturnal urine volume</measure>
    <time_frame>1, 4, 8 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in nocturnal polyuria index</measure>
    <time_frame>1, 4, 8 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the effect on sleep disturbance</measure>
    <time_frame>1, 4, 8 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the impact on quality of life</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events, changes from baseline in serum sodium level, laboratory values</measure>
    <time_frame>During 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Nocturia</condition>
  <arm_group>
    <arm_group_label>A. Desmopressin 10 microgram</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B. Desmopressin 25 microgram</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>C. Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A. Desmopressin 10 microgram</intervention_name>
    <description>1 orally disintegrating tablet every night during study period</description>
    <arm_group_label>A. Desmopressin 10 microgram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>B: Desmopressin 25 microgram</intervention_name>
    <description>1 orally disintegrating tablet every night during study period</description>
    <arm_group_label>B. Desmopressin 25 microgram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>C: Placebo</intervention_name>
    <description>1 orally disintegrating tablet every night during study period</description>
    <arm_group_label>C. Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has given written consent prior to any trial-related activity is performed.&#xD;
&#xD;
          -  Female sex, aged 20 years or older.&#xD;
&#xD;
          -  At least 2 nocturnal voids every night in a consecutive 3-day period as documented in&#xD;
             the diary during the screening period.&#xD;
&#xD;
          -  Has given agreement about contraception during the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Showing symptoms of any of the following diseases: Interstitial cystitis; Overactive&#xD;
             bladder, defined as &gt;6 daytime voids,≥1 urgency episode and ≥1 urge urinary&#xD;
             incontinence episode per 24 hours as documented in the 3-day diary period; Severe&#xD;
             stress urinary incontinence.&#xD;
&#xD;
          -  Psychogenic or habitual polydipsia.&#xD;
&#xD;
          -  Urinary retention or a post void residual volume in excess of 150 mL as confirmed by&#xD;
             bladder ultrasound performed after suspicion of urinary retention.&#xD;
&#xD;
          -  Cancer.&#xD;
&#xD;
          -  A history of urologic malignancies or a history of cancer which has not been in&#xD;
             remission for the last 5 years.&#xD;
&#xD;
          -  Genito-urinary tract pathology.&#xD;
&#xD;
          -  Neurogenic detrusor activity.&#xD;
&#xD;
          -  Suspicion or evidence of heart failure.&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus.&#xD;
&#xD;
          -  Hepatobiliary diseases: Aspartate aminotransferase &gt;80 U/L or alanine aminotransferase&#xD;
             &gt;90 U/L; Total bilirubin &gt;1.5 mg/dL.&#xD;
&#xD;
          -  Renal insufficiency: Serum creatinine level &gt;0.82 mg/dL; Estimated glomerular&#xD;
             filtration rate &lt;50 mL/min.&#xD;
&#xD;
          -  Hyponatraemia: Serum sodium level &lt;135 mEq/L.&#xD;
&#xD;
          -  Central or nephrogenic diabetes insipidus.&#xD;
&#xD;
          -  Syndrome of inappropriate antidiuretic hormone.&#xD;
&#xD;
          -  Obstructive sleep apnea.&#xD;
&#xD;
          -  Previous desmopressin treatment.&#xD;
&#xD;
          -  Treatment with another investigational product within the past 3 months.&#xD;
&#xD;
          -  Concomitant treatment with any prohibited medication.&#xD;
&#xD;
          -  Pregnancy, breastfeeding, or a plan to become pregnant during the period of the&#xD;
             clinical trial.&#xD;
&#xD;
          -  Alcohol or substance abuse.&#xD;
&#xD;
          -  A job or lifestyle that may interfere with regular night-time sleep.&#xD;
&#xD;
          -  A mental condition, lack of decision-making ability, dementia, a speech handicap, or&#xD;
             any other reason which, in the judgement of the investigator (sub-investigator), would&#xD;
             impair the participation in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferríng Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Japanese Red Cross Nagoya Daiichi Hospital</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Tsudanuma</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kato Clinic</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umeyama Clinic</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harada Urology Clinic</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakaguchi Urological Clinic</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakamura Urology Clinic</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nishi-Yokohama International Hospital</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Shinmidori General Hospital</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Izumino Hospital, Bouchikai</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kamei Clinic</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Den Urology Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwasa Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanno Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morimoto Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naka Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uemura Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology department Kuroda Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamaguchi Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamanaka Clinic</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuda Clinic</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yasuda Urology Clinic</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirano Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirata Internal Medicine Urology Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Tower Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koganeibashi Sakura Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kunitachi Sakura Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kusunoki Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moriguchi Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakanoma Clinic Urology Department</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogawa Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogikubo Ekimae Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shibuya Shin-minamiguchi Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Kamata Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toru Clinic</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>August 22, 2013</last_update_submitted>
  <last_update_submitted_qc>August 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2013</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>Nocturia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deamino Arginine Vasopressin</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/NCT01684800
org study id: 000029
nct id: NCT01684800
lead sponsor: 
has dmc: No
The purpose of the study is to investigate the efficacy and safety of two different dose
      levels of desmopressin orally disintegrating tablets against placebo for the treatment of
      nocturia in adult women during 12 weeks treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in mean number of nocturnal voids
time frame: During 12 weeks
measure: Change from baseline in mean time to first void
time frame: During 12 weeks
measure: Responder status (33% reduction in nocturnal voids)
time frame: During 12 weeks
measure: Change from baseline in mean number of nocturnal voids
time frame: 1, 4, 8 and 12 weeks
measure: Change from baseline in mean time to first void
time frame: 1, 4, 8 and 12 weeks
measure: Responder status (33% reduction in nocturnal voids)
time frame: 1, 4, 8 and 12 weeks
measure: Change from baseline in mean nocturnal urine volume
time frame: 1, 4, 8 and 12 weeks
measure: Change from baseline in nocturnal polyuria index
time frame: 1, 4, 8 and 12 weeks
measure: Change from baseline in the effect on sleep disturbance
time frame: 1, 4, 8 and 12 weeks
measure: Change from baseline in the impact on quality of life
time frame: 12 weeks
measure: Adverse events, changes from baseline in serum sodium level, laboratory values
time frame: During 12 weeks
arm group label: A. Desmopressin 10 microgram
arm group type: Active Comparator
arm group label: B. Desmopressin 25 microgram
arm group type: Active Comparator
arm group label: C. Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: A. Desmopressin 10 microgram
description: 1 orally disintegrating tablet every night during study period
arm group label: A. Desmopressin 10 microgram
intervention type: Drug
intervention name: B: Desmopressin 25 microgram
description: 1 orally disintegrating tablet every night during study period
arm group label: B. Desmopressin 25 microgram
intervention type: Drug
intervention name: C: Placebo
description: 1 orally disintegrating tablet every night during study period
arm group label: C. Placebo
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferríng Pharmaceuticals
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country: Japan
responsible party type: Sponsor
mesh term: Nocturia
mesh term: Deamino Arginine Vasopressin