Current partner codePEPTIDESDE
NCT01439997·Phase 4·INTERVENTIONAL

Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

Status

Completed

Phase

Phase 4

Enrollment

5

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Desmopressin

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

Timeline

From registration to results.

  1. First posted

    Sep 23, 2011

  2. Study start

    Mar 26, 2012

  3. Primary completion

    Feb 1, 2013

  4. Study completion

    Feb 1, 2015

  5. Results posted

    Not reported

  6. Registry updated

    Dec 15, 2022

Outcomes

What the study measures.

Primary outcomes

Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.

Time frame · At day 3 after first desmopressin intake.

Urine sample for urine concentration of Na+, K+, creatinin and osmolality

Time frame · At day 3

Area Under Curve (AUC) frequency/volume chart during the first 14 days

Time frame · Every day during the first 14 days.

The decrease of number of nocturnal micturition episodes.

Time frame · At day 0

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

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

Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.

Time frame · At day 7 after first desmopressin intake

Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.

Time frame · At day 30 after first desmopressin intake

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Belgium. Showing up to 24 locations stored in the fast local snapshot.

University Hospital Ghent

Ghent, Belgium

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Desmopressin.

Related PeptideStat pages

Put the record in context.

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