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

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ClinicalTrials.gov Identifier: NCT02904759
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Nocturia Drug: Desmopressin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Male Subjects
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Desmopressin 25 µg
Desmopressin ODT
Drug: Desmopressin
Other Name: FE 992026

Experimental: Desmopressin 50 µg
Desmopressin ODT
Drug: Desmopressin
Other Name: FE 992026

Placebo Comparator: Placebo
Placebo ODT
Drug: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Change from baseline in mean nocturnal urine volume [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the 3-day voiding diary

  3. Change from baseline in mean Nocturnal Polyuria Index (NPI) [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the 3-day voiding diary

  4. Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) [ Time Frame: Week 8 and 12 ]
  5. Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: Week 8 and 12 ]
  6. Change from baseline in bother score [ Time Frame: Week 8 and 12 ]
    Assessed by the Hsu 5-point Likert bother scale

  7. Frequency and severity of adverse events [ Time Frame: From screening to week 12 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to performance of any trial-related activity
  • Man ≥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
    • Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and:

      • Urinary flow <5 mL/s or
      • Post-void residual volume >150 mL
    • 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) or BPH 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
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904759


Locations
Japan
Investigational site (there may be other sites in this country)
Tokyo, Japan
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02904759     History of Changes
Other Study ID Numbers: 000130
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Nocturia
Polyuria
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs