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Study of Minirin Melt® in Adult Patients With Nocturia

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT03089073
Collaborator
(none)
835
Enrollment
1
Location
38.8
Actual Duration (Months)
21.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
835 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia
Actual Study Start Date :
Jul 13, 2015
Actual Primary Completion Date :
Oct 5, 2018
Actual Study Completion Date :
Oct 5, 2018

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in mean number of nocturnal voids [Baseline and treatment-related visits up to 3 months]

    Calculated by 72 hour frequency volume chart (FVC)

Secondary Outcome Measures

  1. Reduction from baseline in the mean number of nocturnal voids [Baseline and treatment-related visits up to 3 months]

    Assessed as a (50% decrease) or reduction of nocturnal diuresis (>20%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult aged between 19 and 65 years

  • Patients having nocturia

  • Decision made to prescribe Minirin Melt according to prescription information

  • Willingness and ability to provide written informed consent

Exclusion Criteria:

  • When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)

  • When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis

  • When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)

  • When patients have known hyponatremia

  • When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

  • When patients have hypersensitivity to the active substances or to any of the excipients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daegu Fatima Hospital (there may be other sites in this country) Daegu Korea, Republic of

Sponsors and Collaborators

  • Ferring Pharmaceuticals

Investigators

  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03089073
Other Study ID Numbers:
  • 000208
First Posted:
Mar 24, 2017
Last Update Posted:
Feb 5, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nocturia
Deamino Arginine Vasopressin

Study Results

No Results Posted as of Feb 5, 2021