Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2010 |
End Date: | November 2011 |
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females
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.
investigate the safety and efficacy of desmopressin oral melt tablets against placebo during
3 months of treatment in adult females with nocturia.
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
We found this trial at
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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