Daytime Impact Sleep Study

NCT01779466 | Terminated Phase 2

• 2 other identifiers: 0000882012-004388-34
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nocturia

Outcome Measures

Primary Outcomes (16)

• Mean number of nocturnal voids

  As measured by voiding diary

  1 month and 3 months

• Wake after sleep onset

  i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography

  1 month and 3 months

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

  Daytime performance

  1 month and 3 months

• Mean time to first void

  As measured by voiding diary

  1 month and 3 months

• Sleep efficiency

  Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography

  1 month and 3 months

• 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

  Measured by Polysomnography

  1 month and 3 months

• Number of awakenings due to nocturia

  Measured by Polysomnography

  1 month and 3 months

• Latency to slow-wave sleep

  Measured by Polysomnography

  1 month and 3 months

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

  Measured by Actigraphy

  1 month and 3 months

• Percent of sleep

  Measured by Actigraphy

  1 month and 3 months

• Number of awakenings due to nocturia

  Measured by Actigraphy

  1 month and 3 months

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

  Daytime performance

  1 month and 3 months

• Safety - incidence of adverse events

  1 month and 3 months

• Safety - clinically significant changes in lab values

  1 week and 3 months

• Safety - clinically significant changes in vital signs

  1 week, 1 month and 3 months

• Safety - clinically significant changes in physical examination

  3 months

Study Arms (3)

Experimental A

EXPERIMENTAL

Drug: Desmopressin

Experimental B

EXPERIMENTAL

Drug: Desmopressin

Placebo

PLACEBO COMPARATOR

Drug: Placebo (not active)

Interventions

Desmopressin DRUG

Experimental A; Experimental B

Placebo (not active) DRUG

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Surrey Clinical Research Centre

Surrey, United Kingdom

Location

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 30, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

GB (1)