Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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

Condition Intervention Phase
Nocturia
Drug: Desmopressin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desmopressin Melt Therapy in Nocturnal Polyuria Patients Drug: Desmopressin
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Other Name: Minirin Melt 60 µg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439997

Contacts
Contact: An-Sofie Goessaert, MD, PhD ansofie.goessaert@ugent.be

Locations
Belgium
University Hospital Ghent Not yet recruiting
Ghent, Belgium, 9000
Principal Investigator: Karel Everaert, MD, PhD         
Sub-Investigator: An-Sofie Goessaert, MD         
Sub-Investigator: Johan Vande Walle, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Karel Everaert, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01439997     History of Changes
Other Study ID Numbers: 2011/567
Study First Received: September 14, 2011
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Nocturnal polyuria

Additional relevant MeSH terms:
Polyuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014