Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Study Overview
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Brief Summary
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Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year

Official Title
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A Multi-Centre Trial Investigating the Long Term Safety and Tolerability of Desmopressin (FE 992026) Orally Disintegrating Tablets for the Treatment of Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Conditions
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Nocturia

Intervention / Treatment
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* Drug: Desmopressin ODT 25 μg
* Drug: Desmopressin ODT 50 μg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (for subjects who participated in trials 000129 or 000130): Written informed consent prior to performance of any trial-related activity for the 000131 trial Has completed participation in trial 000129 or 000130 Exclusion Criteria (for subjects who participated in trials 000129 or 000130): Hyponatraemia (serum sodium level <135 mmol/L) at Visit 7 in trial 000129 or 000130 Withdrawal from clinical trial 000129 or 000130 Inclusion Criteria (for subjects who did not participate in trials 000129 or 000130): Written informed consent prior to performance of any trial-related activity Adult ≥20 years of age Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1a Nocturnal polyuria at the end of screening period prior to Visit 1b Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1a and Visit 1b Has given agreement about contraception during the trial Exclusion Criteria (for subjects who did not participate in trials 000129 or 000130): Early withdrawal from clinical trial 000129 or 000130 Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 1b History or evidence of significant obstructive sleep apnoea History or diagnosis of any of the following urological diseases: Interstitial cystitis or bladder pain disorder In males, 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 prostatitis/chronic pelvic pain syndrome Surgical treatment, including transurethral resection, for BOO or BPH within the past 6 months prior to Visit 1a Symptoms of severe over-active bladder (OAB): Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1a 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 1b Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1a Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1a Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1a History of any neurological disease affecting bladder function or muscle strength at Visit 1a Habitual or psychogenic polydipsia based on medical history at Visit 1a or 24-hour urine output of >2.8 L based on the voiding diary at Visit 1b Central or nephrogenic diabetes insipidus at Visit 1a Syndrome of inappropriate antidiuretic hormone secretion at Visit 1a Suspicion or evidence of cardiac failure at Visit 1a Uncontrolled hypertension at Visit 1a and Visit 1b Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1a Renal insufficiency at Visit 1a and Visit 1b Renal insufficiency at Visit 1a and Visit 1b Hepatic and/or biliary diseases at Visit 1a and Visit 1b Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1a In females, pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Known alcohol or substance abuse at Visit 1a Work or lifestyle that may interfere with regular night-time sleep at Visit 1a, 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 1a 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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All

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
Interventional Model Description: The trial is designed as partly an extension trial for subjects completing trial 000129 (female subjects) and 000130 (male subjects) and partly as a trial for new female and male subjects.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin ODT 25 μg (female previous on 25 μg)<br>Subjects received 25 μg in trial 000129. | Drug: Desmopressin ODT 25 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 25 μg (female previously on placebo)<br>Subjects received placebo in trial 000129 | Drug: Desmopressin ODT 25 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 25 μg (female)<br>New female subjects | Drug: Desmopressin ODT 25 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 25 μg (male previous on 25 μg)<br>Subjects received 25 μg in trial 000130 | Drug: Desmopressin ODT 25 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 50 μg (male previous on 50 μg)<br>Subjects received 50 μg in trial 000130 | Drug: Desmopressin ODT 50 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 50 μg (male previous on placebo)<br>Subjects received placebo in trial 000130 | Drug: Desmopressin ODT 50 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 25 μg (male)<br>Subjects received placebo in trial 000130 | Drug: Desmopressin ODT 25 μg<br> <br> * Other names: FE 992026;|
| Experimental: Desmopressin ODT 50 μg (male)<br>New male subjects | Drug: Desmopressin ODT 50 μg<br> <br> * Other names: FE 992026;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency and severity of adverse events | During long-term treatment | Up to 1 year | 
| Clinically significant changes in laboratory values and vital signs | During long-term treatment | Up to 1 year | 
| The incidence and severity of hyponatraemia | Measured by serum sodium levels during long-term treatment | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of nocturnal voids |  | Week 12, 24, 40 and 52 | 
| Change from baseline in mean time to first awakening to void |  | Week 12, 24, 40 and 52 | 
| Change from baseline in mean nocturnal urin volume |  | Week 12, 24, 40 and 52 | 
| Change from baseline in mean Nocturnal Polyuria Index (NPI) |  | Week 12, 24, 40 and 52 | 
| Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) |  | Week 12, 24, 40 and 52 | 
| Change from baseline in Insomnia Severity Index (ISI) |  | Week 12, 24, 40 and 52 | 
| Change from baseline in bother score | Assessed by the Hsu 5-point Likert bother scale | Week 12, 24, 40 and 52 |