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A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552395
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : May 24, 2016
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

Condition or disease

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Study Type : Observational
Actual Enrollment : 4136 participants
Time Perspective: Prospective
Official Title: A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic
Study Start Date : March 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Number of changes in dosage regime [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Patients Suffering From Nocturia 1x or More Times a Night

Inclusion Criteria:

  • nocturia

Exclusion Criteria:

  • habitual or psychogenic polydipsia,
  • known or suspected cardiac insufficiency
  • other conditions requiring treatment with diuretics
  • moderate and severe renal insufficiency
  • known hyponatremia
  • syndrome of inappropriate ADH secretion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552395

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Sponsors and Collaborators
Ferring Pharmaceuticals
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals Identifier: NCT01552395    
Other Study ID Numbers: 000056
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations