Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Women

Study Overview
=================
Brief Summary
-----------------
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

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

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: A. Desmopressin 10 microgram
* Drug: B: Desmopressin 25 microgram
* Drug: C: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has given written consent prior to any trial-related activity is performed. Female sex, aged 20 years or older. At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period. Has given agreement about contraception during the trial. Exclusion Criteria: Showing symptoms of any of the following diseases: Interstitial cystitis; Overactive bladder, defined as >6 daytime voids,≥1 urgency episode and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence. Psychogenic or habitual polydipsia. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention. Cancer. A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years. Genito-urinary tract pathology. Neurogenic detrusor activity. Suspicion or evidence of heart failure. Uncontrolled hypertension. Uncontrolled diabetes mellitus. Hepatobiliary diseases: Aspartate aminotransferase >80 U/L or alanine aminotransferase >90 U/L; Total bilirubin >1.5 mg/dL. Renal insufficiency: Serum creatinine level >0.82 mg/dL; Estimated glomerular filtration rate <50 mL/min. Hyponatraemia: Serum sodium level <135 mEq/L. Central or nephrogenic diabetes insipidus. Syndrome of inappropriate antidiuretic hormone. Obstructive sleep apnea. Previous desmopressin treatment. Treatment with another investigational product within the past 3 months. Concomitant treatment with any prohibited medication. Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Alcohol or substance abuse. A job or lifestyle that may interfere with regular night-time sleep. A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A. Desmopressin 10 microgram<br> | Drug: A. Desmopressin 10 microgram<br>* 1 orally disintegrating tablet every night during study period<br>|
| Active Comparator: B. Desmopressin 25 microgram<br> | Drug: B: Desmopressin 25 microgram<br>* 1 orally disintegrating tablet every night during study period<br>|
| Placebo Comparator: C. Placebo<br> | Drug: C: Placebo<br>* 1 orally disintegrating tablet every night during study period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of nocturnal voids |  | During 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean time to first void |  | During 12 weeks | 
| Responder status (33% reduction in nocturnal voids) |  | During 12 weeks | 
| Change from baseline in mean number of nocturnal voids |  | 1, 4, 8 and 12 weeks | 
| Change from baseline in mean time to first void |  | 1, 4, 8 and 12 weeks | 
| Responder status (33% reduction in nocturnal voids) |  | 1, 4, 8 and 12 weeks | 
| Change from baseline in mean nocturnal urine volume |  | 1, 4, 8 and 12 weeks | 
| Change from baseline in nocturnal polyuria index |  | 1, 4, 8 and 12 weeks | 
| Change from baseline in the effect on sleep disturbance |  | 1, 4, 8 and 12 weeks | 
| Change from baseline in the impact on quality of life |  | 12 weeks | 
| Adverse events, changes from baseline in serum sodium level, laboratory values |  | During 12 weeks |