NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

Completed

• Conditions: Adverse Drug Event
• Interventions: Other: NOCDURNA Cohort; Other: LUTS Cohort

• Registration Number: NCT04740645
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-07-13
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1099545

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NOCDURNA cohort	NOCDURNA Cohort	-
Lower urinary tract symptoms (LUTS) Cohort	LUTS Cohort	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of symptomatic hyponatraemia	Through study completion, typically 2 months	Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events of MACE and VTE in Sweden	Through study completion, typically 2 months
Incidence rate of hyponatraemia requiring hospital intensive care	Through study completion, typically 2 months	Hyponatraemia requiring hospital intensive care was defined as a primary or secondary diagnosis of hyponatraemia recorded in an intensive care unit.
Incidence and severity of clinically significant hyponatraemia	Through study completion, typically 2 months	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).
Rate of all-cause mortality	Through study completion, typically 2 months	All-cause mortality was defined as death from any cause.
Incidence rate of major venous thromboembolic events (VTEs)	Through study completion, typically 2 months	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.
Incidence rate of major adverse cardiovascular events (MACE)	Through study completion, typically 2 months	Major adverse cardiovascular events were defined as a record of myocardial infarction and stroke. Fatal and non-fatal events will be considered separately.
Incidence rate acute exacerbation of congestive heart failure	Through study completion, typically 2 months	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.

Trial Locations

Locations (1)

German health care register, BIPS (there may be other sites); 🇩🇪 Bremen, Germany