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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Nocturnal Polyuria
Drug: Desmopressin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nocturnal polyuria patient with desmopressin MELT Drug: Desmopressin
120 µg, oral lyophilisate, sublingual use
Other Name: Minirin Melt 120 µg, H01BA02

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435083

Contacts
Contact: An-Sofie Goessaert, MD ansofie.goessaert@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Karel Everaert, MD, PhD       karel.everaert@uzgent.be   
Principal Investigator: Karel Everaert, MD, PhD         
Sub-Investigator: An-Sofie Goessaert, MD         
Sub-Investigator: Johan Vande Walle, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Karel Everaert, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01435083     History of Changes
Other Study ID Numbers: 2011/566
Study First Received: September 13, 2011
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Nocturia

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

ClinicalTrials.gov processed this record on October 23, 2014