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Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects

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ClinicalTrials.gov Identifier: NCT02905682
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date September 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
Change from baseline in mean number of nocturnal voids during 12 weeks of treatment [ Time Frame: Week 1, 4, 8 and 12 ]
Assessed by the 3-day voiding diary
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • Change from baseline in mean time to first awakening to void [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the 3-day voiding diary
  • Change from baseline in mean nocturnal urine volume [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the 3-day voiding diary
  • Change from baseline in mean Nocturnal Polyuria Index (NPI) [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the 3-day voiding diary
  • Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) [ Time Frame: Week 8 and 12 ]
  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: Week 8 and 12 ]
  • Change from baseline in bother score [ Time Frame: Week 8 and 12 ]
    Assessed by the Hsu 5-point Likert bother scale
  • Frequency and severity of adverse events [ Time Frame: From screening to week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects
Brief Summary The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nocturia
Intervention  ICMJE
  • Drug: Desmopressin
    Other Name: FE 992026
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Desmopressin
    Desmopressin ODT
    Intervention: Drug: Desmopressin
  • Placebo Comparator: Placebo
    Placebo ODT
    Intervention: Drug: Placebo
Publications * Yamaguchi O, Juul KV, Falahati A, Yoshimura T, Imura F, Kitamura M. Efficacy and safety of 25 and 50 μg desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program. Low Urin Tract Symptoms. 2020 Jan;12(1):8-19. doi: 10.1111/luts.12276. Epub 2019 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2017)
190
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
178
Actual Study Completion Date  ICMJE September 27, 2017
Actual Primary Completion Date September 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent prior to performance of any trial-related activity
  • Woman ≥20 years of age
  • Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1
  • ≥2 nocturnal voids at the end of screening period prior to Visit 2
  • Nocturnal polyuria at the end of screening period prior to Visit 2
  • Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2
  • Has given agreement about contraception during the trial

Exclusion Criteria:

  • Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
  • History or evidence of significant obstructive sleep apnoea
  • History or diagnosis of any of the following urological diseases at Visit 1:

    • Interstitial cystitis or bladder pain disorder
    • Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history
    • Chronic pelvic pain syndrome
  • Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) within the past 6 months prior to Visit 1
  • Symptoms of severe over-active bladder (OAB):

    • Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1
    • Defined as a mean of >8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to Visit 2
  • Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1
  • Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1
  • Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1
  • History of any neurological disease affecting bladder function or muscle strength at Visit 1
  • Urinary retention or a post void residual volume >150 mL
  • Habitual or psychogenic polydipsia based on medical history at Visit 1 or 24 hour urine output of >2.8 L based on the voiding diary at Visit 2
  • Central or nephrogenic diabetes insipidus at Visit 1
  • Syndrome of inappropriate antidiuretic hormone secretion at Visit 1
  • Suspicion or evidence of cardiac failure at Visit 1
  • Uncontrolled hypertension at Visit 1
  • Uncontrolled diabetes mellitus at Visit 1
  • Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1
  • Renal insufficiency at Visit 1
  • Hepatic and/or biliary diseases at Visit 1
  • Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1
  • Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
  • Known alcohol or substance abuse at Visit 1
  • Work or lifestyle that may interfere with regular night-time sleep at Visit 1, e.g., shift workers
  • Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at Visit 1
  • Use of any prohibited therapy during the trial period
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905682
Other Study ID Numbers  ICMJE 000129
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP