Overview

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

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ferring Pharmaceuticals
Treatments:
Deamino Arginine Vasopressin
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.