Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Group A:
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).
Group B:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desmopressin Melt Therapy in Nocturnal Polyuria Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug | Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3. | At day 3 after first desmopressin intake. | |
| Urine sample for urine concentration of Na+, K+, creatinin and osmolality | At day 3 | |
| Area Under Curve (AUC) frequency/volume chart during the first 14 days | Every day during the first 14 days. | |
| The decrease of number of nocturnal micturition episodes. | Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes. | At day 0 |
| The decrease of the number of nocturnal micturition episodes. | Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes | At day 30 |
| Registration of number of side effects at day 3. | At day 3 | |
| Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7. | At day 7 after first desmopressin intake | |
| Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30. | At day 30 after first desmopressin intake | |
| Registration of number of side effects at day 7 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karel Everaert, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At day 7 |
| Registration of number of side effects at day 30. | At day 30 |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |