Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
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|ClinicalTrials.gov Identifier: NCT01439997|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : September 23, 2011
Last Update Posted : December 5, 2014
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 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?
The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.
There are two groups of patients:
Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).
This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.
The study starts when the patients takes his first prescribed Minirin Melt tablet:
- On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
- On day 3 the patient has to give a urine sample.
- Patients have to fill out a frequency/volume chart during the first 14 days.
- On day 30, a 3rd blood sample will be taken
|Condition or disease||Intervention/treatment||Phase|
|Nocturia||Drug: Desmopressin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||July 2015|
|Experimental: Desmopressin Melt Therapy in Nocturnal Polyuria Patients||
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Other Name: Minirin Melt 60 µg
- Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3. [ Time Frame: At day 3 after first desmopressin intake. ]
- Urine sample for urine concentration of Na+, K+, creatinin and osmolality [ Time Frame: At day 3 ]
- Area Under Curve (AUC) frequency/volume chart during the first 14 days [ Time Frame: Every day during the first 14 days. ]
- The decrease of number of nocturnal micturition episodes. [ Time Frame: At day 0 ]Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
- The decrease of the number of nocturnal micturition episodes. [ Time Frame: At day 30 ]Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
- Registration of number of side effects at day 3. [ Time Frame: At day 3 ]
- Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7. [ Time Frame: At day 7 after first desmopressin intake ]
- Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30. [ Time Frame: At day 30 after first desmopressin intake ]
- Registration of number of side effects at day 7 [ Time Frame: At day 7 ]
- Registration of number of side effects at day 30. [ Time Frame: At day 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439997
|Contact: An-Sofie Goessaert, MD, PhDemail@example.com|
|University Hospital Ghent||Recruiting|
|Ghent, Belgium, 9000|
|Principal Investigator: Karel Everaert, MD, PhD|
|Sub-Investigator: An-Sofie Goessaert, MD|
|Sub-Investigator: Johan Vande Walle, MD, PhD|
|Principal Investigator:||Karel Everaert, MD, PhD||University Hospital, Ghent|