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Daytime Impact Sleep Study

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nocturia

Intervention: Desmopressin (Drug); Placebo (not active) (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Summary

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.

Clinical Details

Official title: A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean number of nocturnal voids

Wake after sleep onset

Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale

Mean time to first void

Sleep efficiency

Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time

Number of awakenings due to nocturia

Latency to slow-wave sleep

Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset

Percent of sleep

Number of awakenings due to nocturia

Quality of life score measured by EQ-5D-5L

Safety - incidence of adverse events

Safety - clinically significant changes in lab values

Safety - clinically significant changes in vital signs

Safety - clinically significant changes in physical examination

Eligibility

Minimum age: 25 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Surrey Clinical Research Centre, Surrey, United Kingdom
Additional Information

Starting date: April 2013
Last updated: April 24, 2015

Page last updated: August 23, 2015

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