NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

Adverse Drug Event Clinical Trial

Official title:

Post-authorisation Safety Study of NOCDURNA for the Symptomatic Treatment of Nocturia Due to Idiopathic Nocturnal Polyuria: A Multi-country Cohort Study Using Secondary Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740645
• Other study ID #: 000248
• Status: Recruiting
• Start date: July 13, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Ferring Pharmaceuticals
• Contact: Global Clinical Compliance
• Phone: +1 833-548-1402 (US/Canada)
• Email: DK0-Disclosure[@]ferring.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Usage of NOCDURNA recorded as dispensations from drugstores in adults or or usage of drugs for LUTS.

Exclusion Criteria:

• Multiple dispensation of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• NOCDURNA Cohort
Non intervention
• LUTS Cohort
Non intervention

Locations

Country	Name	City	State
Germany	German health care register, BIPS (there may be other sites)	Bremen

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of symptomatic hyponatraemia	Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.	Through study completion, typically 2 months
Secondary	Incidence rate of hyponatraemia requiring hospital intensive care	Hyponatraemia requiring hospital intensive care was defined as a primary or secondary diagnosis of hyponatraemia recorded in an intensive care unit.	Through study completion, typically 2 months
Secondary	Incidence and severity of clinically significant hyponatraemia	Clinically significant hyponatraemia was defined as a serum sodium concentration of <130 mmol/L. Severity of hyponatraemia was categorized as mild hyponatraemia (serum sodium concentration: 130 to <135 mmol/L), moderate hyponatraemia (serum sodium concentration: >125 to <130 mmol/L) and severe hyponatraemia (serum sodium concentration: less than equal to [=]125 mmol/L).	Through study completion, typically 2 months
Secondary	Rate of all-cause mortality	All-cause mortality was defined as death from any cause.	Through study completion, typically 2 months
Secondary	Incidence rate of major adverse cardiovascular events (MACE)	Major adverse cardiovascular events were defined as a record of myocardial infarction and stroke. Fatal and non-fatal events will be considered separately.	Through study completion, typically 2 months
Secondary	Incidence rate of major venous thromboembolic events (VTEs)	Venous thromboembolic events were defined as a record of a deep vein thrombosis, pulmonary embolism or portal vein thrombosis. Fatal and non-fatal events will be considered separately.	Through study completion, typically 2 months
Secondary	Incidence rate acute exacerbation of congestive heart failure	Acute exacerbation of congestive heart failure was defined as primary diagnosis of acute or acute-on-chronic heart failure from hospital inpatient care or the acute and emergency ward, or death from heart failure as the underlying or contributory cause.	Through study completion, typically 2 months
Secondary	Incidence of serious adverse events of MACE and VTE in Sweden		Through study completion, typically 2 months