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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
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring Nocturnal polyuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 14, 2011
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
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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

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Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

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