Study of Minirin Melt® in Adult Patients With Nocturia | NCT03089073

Studies
Study of Minirin Melt® in Adult Patients With Nocturia

NCT03089073

Sponsor

Ferring Pharmaceuticals

Status

Terminated

Last Update Posted

Feb 5, 2021Actual

Enrollment

835Actual

Phase

Not provided

Conditions

Nocturia

Interventions

Desmopressin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment challenges

Expanded Access Info

Start Date

Jul 13, 2015Actual

Primary Completion Date

Oct 5, 2018Actual

Completion Date

Oct 5, 2018Actual

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2021

Last Update Posted Date

Feb 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

835Actual

Name	Type	Description	Arm Group Labels	Other Names
Desmopressin	Drug	60μg or 120μg once daily at bedtime		Minirin Melt®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Compliance	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daegu Fatima Hospital (there may be other sites in this country)		Daegu			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D053158	Nocturia

Ancestor Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003894	Deamino Arginine Vasopressin

Ancestor Terms

ID	Term
D001127	Arginine Vasopressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided