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Completed

NCT Number: NCT01435083

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

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 the evening at 19h (day 2): drink 15mL/kg water * At 20h: take desmopressin melt 120µg + start:

* 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7) * Measurement of blood pressure during 24h * Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake * Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile) * At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h * Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days

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Key information

Conditions

Nocturnal Polyuria Lower Urinary Tract Symptoms Nocturia 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 woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence.

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 < 50 ml/min)
  • psychogenic or habitual polydipsia
  • hyponatraemia or predisposition for hyponatraemia
  • diabetes insipidus
  • syndrome of inadequate ADH production

Treatment and study plan

Desmopressin

Drug

120 µg, oral lyophilisate, sublingual use

Other names: Minirin Melt 120 µg, H01BA02

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Measurement of blood pressure during 24h

    Time frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2011
Registry last updated
Dec 5, 2014

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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