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Clinical Trials/EUCTR2011-004540-22-BE
EUCTR2011-004540-22-BE
Active, not recruiting
Not Applicable

Desmopressin melt therapy in nocturnal polyuria patients: pharmacokinetic/dynamic study

Ghent University Hospital0 sitesSeptember 14, 2011
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Conditionsocturia and noctural polyuriaMedDRA version: 14.0Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Body processes [G] - Biological Phenomena [G16]
DrugsMinirin Melt 120 µg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
octuria and noctural polyuria
Sponsor
Ghent University Hospital
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 14, 2011
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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
  • •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
  • •\- moderate to severe renal insufficiency (creatinin clearance \< 50 ml/min)
  • •\- psychogenic or habitual polydipsia
  • •\- hyponatriemia or predisposition for hyponatriemia
  • •\- diabetes insipidus
  • •\- syndrome of inadequate ADH production

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic studyoctural polyuriaMedDRA version: 14.1Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Body processes [G] - Physiological processes [G07]
EUCTR2011-004560-29-BEGhent University Hospital5
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Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic StudyNocturia
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