Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

NCT01439997 | Completed Phase 4

• 1 other identifier: 2011/567
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Nocturia

Keywords

Nocturnal polyuria

Outcome Measures

Primary Outcomes (10)

• 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

  At day 7

• Registration of number of side effects at day 30.

  At day 30

Study Arms (1)

Desmopressin Melt Therapy in Nocturnal Polyuria Patients

EXPERIMENTAL

Drug: Desmopressin

Interventions

Desmopressin DRUG

Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.

Also known as: Minirin Melt 60 µg

Desmopressin Melt Therapy in Nocturnal Polyuria Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Karel Everaert, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 23, 2011
• Study Start: March 26, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2015
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)