Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

Ferring Pharmaceuticals268 enrolled

Overview

A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

268

Conditions

Nocturia

Interventions

DesmopressinDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent prior to performance of any trial-related activity * Female sex 18 years of age or older * At least 2 voids every night in a consecutive 3-day period during the screening period Exclusion Criteria: 1. Evidence of severe daytime voiding dysfunction defined as: * Urge urinary incontinence (more than 1 episode/day in the 3-day diary period) * Urgency (more than 1 episode/day in the 3-day diary period) * Frequency (more than 8 daytime voids/day in the 3-day diary period) 2. Interstitial cystitis 3. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention 4. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours) 5. Central or nephrogenic diabetes insipidus 6. Syndrome of inappropriate anti-diuretic hormone secretion 7. Current or a history of urologic malignancies e.g. bladder cancer 8. Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms 9. Neurogenic detrusor activity (detrusor overactivity). 10. Suspicion or evidence of cardiac failure 11. Uncontrolled hypertension 12. Uncontrolled diabetes mellitus 13. Hyponatraemia: Serum sodium level must be within normal limits 14. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min 15. Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL 16. History of obstructive sleep apnea 17. Previous desmopressin treatment for nocturia 18. Treatment with another investigational product within 3 months prior to screening 19. Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug 20. Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months' duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test 21. Known alcohol or substance abuse 22. Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers 23. 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

Locations (45)

Outcomes

Primary Outcomes

Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period

The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below. Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.

Time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)

Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3

Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.

Time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)

Secondary Outcomes

Change From Baseline in Mean Number of Nocturnal Voids at Month 3

The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed.

Data from ClinicalTrials.gov

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