Daytime Impact Sleep Study (DAISS)

Ferring

Status and phase

Terminated

Phase 2

Conditions

Nocturia

Treatments

Drug: Placebo (not active)

Drug: Desmopressin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01779466

000088

2012-004388-34 (EudraCT Number)

Details and patient eligibility

About

This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.

Enrollment

5 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 2 night time voids per night
Habitual sleep of 6-9.5 hours per night
Experiencing symptoms of Nocturia greater than 6 months

Exclusion criteria

Greater than 10 night time voids
History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
Other sleep disorders
Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
Urological malignancies
Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)
Central or nephrogenic diabetes insipidus
Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)
Syndrome of inappropriate antidiuretic hormone (SIADH)
Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output
Uncontrolled hypertension
Uncontrolled diabetes mellitus
Hyponatraemia with sodium <135 mmol/L
Renal insufficiency
Known or suspected clinically significant hepatic and/or biliary diseases