Clinical Trial: Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

Brief Summary:

The objective of this study is to find out what the pharmacodynamic (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?

The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.

There are two groups of patients:

Group A:

Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).

Group B:

This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.

The study starts when the patients takes his first prescribed Minirin Melt tablet:

  • On day 3 and day 7 a blood sample will be taken at th

    Detailed Summary:
    Sponsor: University Hospital, Ghent

    Current Primary Outcome:

    • Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3. [ Time Frame: At day 3 after first desmopressin intake. ]
    • Urine sample for urine concentration of Na+, K+, creatinin and osmolality [ Time Frame: At day 3 ]
    • Area Under Curve (AUC) frequency/volume chart during the first 14 days [ Time Frame: Every day during the first 14 days. ]
    • The decrease of number of nocturnal micturition episodes. [ Time Frame: At day 0 ]
      Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
    • The decrease of the number of nocturnal micturition episodes. [ Time Frame: At day 30 ]
      Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
    • Registration of number of side effects at day 3. [ Time Frame: At day 3 ]
    • Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7. [ Time Frame: At day 7 after first desmopressin intake ]
    • Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30. [ Time Frame: At day 30 after first desmopressin intake ]
    • Registration of number of side effects at day 7 [ Time Frame: At day 7 ]
    • Registration of number of side effects at day 30. [ Time Frame: At day 30 ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University Hospital, Ghent

    Dates:
    Date Received: September 14, 2011
    Date Started: February 2013
    Date Completion: July 2015
    Last Updated: December 4, 2014
    Last Verified: December 2014