An observational study in Adverse Drug Event, sponsored by Ferring Pharmaceuticals. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Ferring Pharmaceuticals · Observational
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.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's enrollment of 1,099,551 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with usage of NOCDURNA identified as dispensations/prescriptions or dispensations/prescription of drugs for LUTS
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: NOCDURNA Cohort
Other: LUTS Cohort
Non intervention
Non intervention
Incidence rate of symptomatic hyponatraemia
Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.
Time frame: Through study completion, typically 2 months
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.
Time frame: Through study completion, typically 2 months
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).
Time frame: Through study completion, typically 2 months
Rate of all-cause mortality
All-cause mortality was defined as death from any cause.
Time frame: Through study completion, typically 2 months
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.
Time frame: Through study completion, typically 2 months
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.
Time frame: Through study completion, typically 2 months
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.
Time frame: Through study completion, typically 2 months
Incidence of serious adverse events of MACE and VTE in Sweden
Time frame: Through study completion, typically 2 months
Plan to share: No
Ran from Jul 2021 to primary completion in Nov 2023, 27 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Drug-Related Side Effects and Adverse Reactions →