000278 AWAKEN - Open-label trial of desmopressin ODT

• Research type

  Research Study

• Full title

  An Open-label Trial Investigating the Association Between Nocturia and Sleep During 12 Weeks of Treatment with Desmopressin Orally Disintegrating Tablet (ODT) for Nocturia due to Nocturnal Polyuria in Adults

• IRAS ID

  231038

• Contact name

  Susannah Eyre

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2017-000808-22

• Clinicaltrials.gov Identifier

  128025, IND Number

• Duration of Study in the UK

  1 years, 9 months, 29 days

• Research summary

  Nocturia is defined as waking from sleep (during the night) at least once to urinate. This may occur due to a condition called nocturnal polyuria which is when the body produces excessive amounts of urine during the night. Nocturia is the most common cause of sleep deprivation in older adults which has been associated with decreased quality of life, reduction in cognitive performance and decreased productivity. Other symptoms, reported by patients who suffer from sleep deprivation, include mood disorders and poor physical health.
  The Study Medicine is called Desmopressin, Orally Disintegrating Tablet (ODT). Desmopressin is a synthetic antidiuretic, developed based upon a naturally occurring hormone which controls the production of urine during the night. Previous trials have shown that desmopressin significantly reduces the number of times both men and women are awoken during the night to urinate and at the same time increases the length of sleep they get before they are woken, leading to an increase in quality of life.
  The aim of this trial is to assess the association between nocturia and sleep during 12 weeks of treatment with desmopressin ODT in adults who have nocturnal polyuria. Sleep quality will be measured using patient reported questionnaires. Patients will keep a diary to measure the impact of waking during the night to urinate and they will also wear an actiwatch to objectively assess their sleep.
  During the trial patient's blood and urine samples will be analysed. Additionally, the trial will further assess the safety of desmopressin ODT (25 µg in females and 50 µg in males) for the treatment of nocturia due to nocturnal polyuria.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  17/NE/0330

• Date of REC Opinion

  24 Oct 2017

• REC opinion

  Unfavourable Opinion