Clinical Trial: Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Brief Summary:

The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:

  • Are differences related to the pathophysiological factors involved in nocturia?
  • Are there age/gender/size differences?
  • Can the investigators identify patients who are likely to develop hyponatraemia?
  • Can the investigators individualize treatment and reduce risk for hyponatraemia?

Day 1:

  • Patient is being hospitalized in the morning
  • General anamnesis and clinical examination
  • Uroflow and residue measurements (3x)
  • Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin

Day 1-2:

- In the evening at 20h:

  • start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
  • Measurement of blood pressure during 24h

Day 2-3:

  • In t

    Detailed Summary:
    Sponsor: University Hospital, Ghent

    Current Primary Outcome: Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults [ Time Frame: hospitalisation of 3 days of which 15h specific for primary outcome measurements ]

    • blood analysis for plasma concentration of desmopressin: 1h, 2h, 3h, 6h and 12h after drug intake

    • urine analysis for urinary concentration of sodium, potassium, creatinin and osmolality:

      • after water load with 15ml/kg body weight (evening day 2): the moment of drug intake, 1h, 2h, 3h, 6h and 12h after drug intake
      • after water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 24h miction-incontinence-residue registration: urine collections every 3 hours [ Time Frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h ]

      24h miction-incontinence-residu registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with:

      • Registration of volumes
      • Measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
    • Measurement of blood pressure during 24h [ Time Frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h ]


    Original Secondary Outcome: Same as current

    Information By: University Hospital, Ghent

    Dates:
    Date Received: September 13, 2011
    Date Started: November 2011
    Date Completion:
    Last Updated: December 4, 2014
    Last Verified: December 2014