Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
Primary Purpose
Nocturia
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Desmopressin
Sponsored by
About this trial
This is an interventional treatment trial for Nocturia focused on measuring Nocturnal polyuria
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desmopressin Melt Therapy in Nocturnal Polyuria Patients
Arm Description
Outcomes
Primary Outcome Measures
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.
Urine sample for urine concentration of Na+, K+, creatinin and osmolality
Area Under Curve (AUC) frequency/volume chart 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.
The decrease of the number of nocturnal micturition episodes.
Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
Registration of number of side effects at day 3.
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.
Registration of number of side effects at day 7
Registration of number of side effects at day 30.
Secondary Outcome Measures
Full Information
NCT ID
NCT01439997
First Posted
September 14, 2011
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01439997
Brief Title
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
Official Title
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2012 (Actual)
Primary Completion Date
February 1, 2013 (Actual)
Study Completion Date
February 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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:
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
Nocturnal polyuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin Melt Therapy in Nocturnal Polyuria Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
Minirin Melt 60 µg
Intervention Description
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Primary Outcome Measure Information:
Title
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.
Time Frame
At day 3 after first desmopressin intake.
Title
Urine sample for urine concentration of Na+, K+, creatinin and osmolality
Time Frame
At day 3
Title
Area Under Curve (AUC) frequency/volume chart during the first 14 days
Time Frame
Every day during the first 14 days.
Title
The decrease of number of nocturnal micturition episodes.
Description
Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
Time Frame
At day 0
Title
The decrease of the number of nocturnal micturition episodes.
Description
Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
Time Frame
At day 30
Title
Registration of number of side effects at day 3.
Time Frame
At day 3
Title
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.
Time Frame
At day 7 after first desmopressin intake
Title
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.
Time Frame
At day 30 after first desmopressin intake
Title
Registration of number of side effects at day 7
Time Frame
At day 7
Title
Registration of number of side effects at day 30.
Time Frame
At day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Everaert, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
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