Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Nocturnal Polyuria Clinical Trial

Official title:

Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435083
• Other study ID #: 2011/566
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: December 4, 2014
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to find out what the pharmacokinetic/dynamic (PK/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?

Day 1:

• Patient is being hospitalized in the morning

• General anamnesis and clinical examination

• Uroflow and residue measurements (3x)

• Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin

Day 1-2:

• In the evening at 20h:

• start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin

• Measurement of blood pressure during 24h

Day 2-3:

• In the evening at 19h (day 2): drink 15mL/kg water

• At 20h: take desmopressin melt 120µg + start:

• 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)

• Measurement of blood pressure during 24h

• Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake

• Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile)

• At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h

• Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written informed consent prior to the performance of any study-related activity

• patients, men and woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence.

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 < 50 ml/min)

• psychogenic or habitual polydipsia

• hyponatraemia or predisposition for hyponatraemia

• diabetes insipidus

• syndrome of inadequate ADH production

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia
• Nocturnal Polyuria
• Polyuria

Intervention

Drug:
• Desmopressin
120 µg, oral lyophilisate, sublingual use

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults	blood analysis for plasma concentration of desmopressin: 1h, 2h, 3h, 6h and 12h after drug intake; urine analysis for urinary concentration of sodium, potassium, creatinin and osmolality: after water load with 15ml/kg body weight (evening day 2): the moment of drug intake, 1h, 2h, 3h, 6h and 12h after drug intake; after water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load	hospitalisation of 3 days of which 15h specific for primary outcome measurements	Yes
Secondary	24h miction-incontinence-residue registration: urine collections every 3 hours	24h miction-incontinence-residu registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: Registration of volumes; Measurement urinary concentrations of Na+, Cl-, osmolality and creatinin	2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h	Yes
Secondary	Measurement of blood pressure during 24h		2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h	Yes

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