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Completed

NCT Number: NCT01439997

Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

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 the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days. * On day 3 the patient has to give a urine sample. * Patients have to fill out a frequency/volume chart during the first 14 days. * On day 30, a 3rd blood sample will be taken

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written informed consent prior to the performance of any study-related activity
  • patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
  • evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
  • Diuresis <2.5L

Exclusion criteria

  • hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
  • pregnancy
  • genitourinary tract pathology (infection, tumor,...)
  • urolithiasis
  • suspicion or evidence of cardiac failure
  • moderate to severe renal insufficiency (creatinin clearance < 60 ml/min)
  • psychogenic or habitual polydipsia
  • hyponatraemia or predisposition for hyponatraemia
  • diabetes insipidus
  • syndrome of inadequate ADH production
  • suspicion or evidence of liver failure

Treatment and study plan

Desmopressin

Drug

Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.

Other names: Minirin Melt 60 µg

Primary outcomes

  1. Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.

    Time frame: At day 3 after first desmopressin intake.

  2. Urine sample for urine concentration of Na+, K+, creatinin and osmolality

    Time frame: At day 3

  3. Area Under Curve (AUC) frequency/volume chart during the first 14 days

    Time frame: Every day during the first 14 days.

  4. 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.

  5. 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

  6. Registration of number of side effects at day 3.

    Time frame: At day 3

  7. Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.

    Time frame: At day 7 after first desmopressin intake

  8. Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.

    Time frame: At day 30 after first desmopressin intake

  9. Registration of number of side effects at day 7

    Time frame: At day 7

  10. Registration of number of side effects at day 30.

    Time frame: At day 30

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Sep 23, 2011
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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