Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic study

Phase 1

• Conditions: octural polyuria; MedDRA version: 14.1Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2011-004560-29-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-14
• Study Completion: 2013-02-01
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

- Written informed consent prior to the performance of any study-related activity
- Patients 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
- pregnancy
- genito-urinary tract pathology (infection, tumor,...)
- urolithiasis
- suspicion or evidence of cardiac failure
- suspicion or evidence of liver failure
- moderate to severe renal insufficiency (creatinin clearance < 60 ml/min)
- psychogenic or habitual polydipsia
- hyponatriemia or predisposition for hyponatriemia (sodium < 135 mmol/L) before inclusion
- diabetes insipidus
- syndrome of inadequate ADH production

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the pharmacodynamic (PD) characteristics of desmopressin melt in nocturia patients;Secondary Objective: Safety;Primary end point(s): Urine production;Timepoint(s) of evaluation of this end point: Everyday during the first fourteen days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Blood analysis for safety profile ;Timepoint(s) of evaluation of this end point: On day 3, 7 and 30 after the start of the treatment with desmopressin melt