Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01439997
First received: September 14, 2011
Last updated: February 1, 2013
Last verified: February 2013

September 14, 2011
February 1, 2013
February 2013
June 2013   (final data collection date for primary outcome measure)
  • Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3. [ Time Frame: At day 3 after first desmopressin intake. ] [ Designated as safety issue: No ]
  • Urine sample for urine concentration of Na+, K+, creatinin and osmolality [ Time Frame: At day 3 ] [ Designated as safety issue: Yes ]
  • Area Under Curve (AUC) frequency/volume chart during the first 14 days [ Time Frame: Every day during the first 14 days. ] [ Designated as safety issue: Yes ]
  • The decrease of number of nocturnal micturition episodes. [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7. [ Time Frame: At day 7 after first desmopressin intake ] [ Designated as safety issue: No ]
  • Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30. [ Time Frame: At day 30 after first desmopressin intake ] [ Designated as safety issue: No ]
  • Registration of number of side effects at day 7 [ Time Frame: At day 7 ] [ Designated as safety issue: Yes ]
  • Registration of number of side effects at day 30. [ Time Frame: At day 30 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01439997 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

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
Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nocturia
Drug: Desmopressin
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Other Name: Minirin Melt 60 µg
Experimental: Desmopressin Melt Therapy in Nocturnal Polyuria Patients
Intervention: Drug: Desmopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: An-Sofie Goessaert, MD, PhD ansofie.goessaert@ugent.be
Belgium
 
NCT01439997
2011/567
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Karel Everaert, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP