Phase 3
N=268
Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT01223937 ↗Enrolled (actual)
268
Serious AEs
0.8%
Results posted
Oct 2015
Primary outcome: Primary: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period — -1; -1.21; -1.25; -1.47 nocturnal voids — p=0.0280
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desmopressin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period |
-1; -1.21; -1.25; -1.47; -1.36; -1.57 | 0.0280 sig |
| PRIMARY Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3 |
0.64; 0.76 | 0.0061 sig |
| SECONDARY Change From Baseline in Mean Number of Nocturnal Voids at Month 3 |
-1.38; -1.69 | 0.0104 sig |
| SECONDARY Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3 |
0.69; 0.79 | 0.0586 |
| SECONDARY Change From Baseline in Mean Time to First Nocturnal Void at Month 3 |
115; 168 | 0.0034 sig |
| SECONDARY Change From Baseline in Nocturnal Urine Volume at Month 3 |
-151; -242 | 0.0031 sig |
| SECONDARY Change From Baseline in 24-Hour Urine Volume at Month 3 |
-152; -255 | 0.1829 |
| SECONDARY Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) |
57; 60; 3; 1; 15; 26 | — |
| SECONDARY Minimum Post-Treatment Serum Sodium Levels |
0; 0; 0; 3; 2; 11 | — |
Summary
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.
Eligibility Criteria
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
- 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)
- Interstitial cystitis
- Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
- Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
- Central or nephrogenic diabetes insipidus
- Syndrome of inappropriate anti-diuretic hormone secretion
- Current or a history of urologic malignancies e.g. bladder cancer
- Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms
- Neurogenic detrusor activity (detrusor overactivity).
- Suspicion or evidence of cardiac failure
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Hyponatraemia: Serum sodium level must be within normal limits
- Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
- 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
- History of obstructive sleep apnea
- Previous desmopressin treatment for nocturia
- Treatment with another investigational product within 3 months prior to screening
- Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
- 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
- Known alcohol or substance abuse
- Work or lifestyle that may interfere with regular nighttime sleep 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
Data sourced from ClinicalTrials.gov (NCT01223937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.