Status:
COMPLETED
Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
Lead Sponsor:
University Hospital, Ghent
Conditions:
Nocturnal Polyuria
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01435083
Start Date
November 1 2011
End Date
July 1 2013
Last Update
December 5 2014
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000