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

NCT01435083 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-12-05

No results posted yet for this study

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

Conditions

  • Nocturnal Polyuria

Interventions

DRUG

Desmopressin

120 µg, oral lyophilisate, sublingual use

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Karel Everaert, MD, PhD · University Hospital, Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435083 on ClinicalTrials.gov