Study of Minirin Melt® in Adult Patients With Nocturia

February 2, 2021 updated by: Ferring Pharmaceuticals

Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

835

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Daegu Fatima Hospital (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Only patients to whom Minirin melt is prescribed as regular treatment is included in accordance with their usual practice and consistent with Korean prescribing information for Minirin melt.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean number of nocturnal voids
Time Frame: Baseline and treatment-related visits up to 3 months
Calculated by 72 hour frequency volume chart (FVC)
Baseline and treatment-related visits up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction from baseline in the mean number of nocturnal voids
Time Frame: Baseline and treatment-related visits up to 3 months
Assessed as a (50% decrease) or reduction of nocturnal diuresis (>20%)
Baseline and treatment-related visits up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2015

Primary Completion (ACTUAL)

October 5, 2018

Study Completion (ACTUAL)

October 5, 2018

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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