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

NCT01435083 | Completed Phase 4

• 1 other identifier: 2011/566
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nocturnal Polyuria

Keywords

Nocturia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 24h miction-incontinence-residue registration: urine collections every 3 hours

  2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h

• Measurement of blood pressure during 24h

  2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h

Study Arms (1)

nocturnal polyuria patient with desmopressin MELT

EXPERIMENTAL

Drug: Desmopressin

Interventions

Desmopressin DRUG

120 µg, oral lyophilisate, sublingual use

Also known as: Minirin Melt 120 µg, H01BA02

nocturnal polyuria patient with desmopressin MELT

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

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 \< 50 ml/min)
• psychogenic or habitual polydipsia
• hyponatraemia or predisposition for hyponatraemia
• diabetes insipidus
• syndrome of inadequate ADH production

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 15, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

BE (1)