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

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ClinicalTrials.gov Identifier: NCT01435083
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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 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

Condition or disease Intervention/treatment Phase
Nocturnal Polyuria Drug: Desmopressin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nocturnal polyuria patient with desmopressin MELT Drug: Desmopressin
120 µg, oral lyophilisate, sublingual use
Other Name: Minirin Melt 120 µg, H01BA02




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435083


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Karel Everaert, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01435083     History of Changes
Other Study ID Numbers: 2011/566
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Nocturia

Additional relevant MeSH terms:
Polyuria
Nocturia
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Lower Urinary Tract Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs