Status:
COMPLETED
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
Lead Sponsor:
University Hospital, Ghent
Conditions:
Nocturia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions...
Eligibility Criteria
Inclusion
- written informed consent prior to the performance of any study-related activity
- patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
- evidence for nocturnal polyuria (nocturnal urine volume \>33% of total volume over 24h), determined on frequency/volume chart
- Diuresis \<2.5L
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 \< 60 ml/min)
- psychogenic or habitual polydipsia
- hyponatraemia or predisposition for hyponatraemia
- diabetes insipidus
- syndrome of inadequate ADH production
- suspicion or evidence of liver failure
Key Trial Info
Start Date :
March 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01439997
Start Date
March 26 2012
End Date
February 1 2015
Last Update
December 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Ghent
Ghent, Belgium, 9000