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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nocturia

Intervention / Treatment
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* Drug: Desmopressin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin<br>Desmopressin ODT | Drug: Desmopressin<br> <br> * Other names: FE 992026;|
| Placebo Comparator: Placebo<br>Placebo ODT | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of nocturnal voids during 12 weeks of treatment | Assessed by the 3-day voiding diary | Week 1, 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean time to first awakening to void | Assessed by the 3-day voiding diary | Week 1, 4, 8 and 12 | 
| Change from baseline in mean nocturnal urine volume | Assessed by the 3-day voiding diary | Week 1, 4, 8 and 12 | 
| Change from baseline in mean Nocturnal Polyuria Index (NPI) | Assessed by the 3-day voiding diary | Week 1, 4, 8 and 12 | 
| Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) |  | Week 8 and 12 | 
| Change from baseline in Insomnia Severity Index (ISI) |  | Week 8 and 12 | 
| Change from baseline in bother score | Assessed by the Hsu 5-point Likert bother scale | Week 8 and 12 | 
| Frequency and severity of adverse events |  | From screening to week 12 |