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

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01435083
First received: September 13, 2011
Last updated: February 1, 2013
Last verified: February 2013

September 13, 2011
February 1, 2013
November 2011
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
  • 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
Same as current
Complete list of historical versions of study NCT01435083 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nocturnal Polyuria
Drug: Desmopressin
120 µg, oral lyophilisate, sublingual use
Other Name: Minirin Melt 120 µg, H01BA02
Experimental: nocturnal polyuria patient with desmopressin MELT
Intervention: Drug: Desmopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: An-Sofie Goessaert, MD ansofie.goessaert@ugent.be
Belgium
 
NCT01435083
2011/566
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Karel Everaert, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP