A Study of Minirin Melt in Patients With Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01212224
First received: September 21, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

This is a confirmation of safety profile for Minirin Melt in clinical practice.


Condition
Nocturia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Verify the safety profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety aspect of dosage [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 2187
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • nocturia

Exclusion Criteria:

  • habitual or psychogenic polydipsia
  • known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics
  • moderate and severe renal insufficiency
  • know hyponatremia
  • syndrome of inappropriate ADH secretion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212224

  Show 83 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01212224     History of Changes
Other Study ID Numbers: FE992026 CS37
Study First Received: September 21, 2010
Last Updated: January 3, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014