NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adverse Drug Event
• Intervention / Treatment: Other: NOCDURNA Cohort; Other: LUTS Cohort

• Study Type: Observational
• Enrollment (Estimated): 300000

Contacts and Locations

• Study Contact: Name: Global Clinical Compliance; Phone Number: +1 833-548-1402 (US/Canada); Email: DK0-Disclosure@ferring.com
• Study Contact Backup: Name: Global Clinical Compliance; Phone Number: +1 862-286-5200 (outside US); Email: DK0-Disclosure@ferring.com

Study Locations

• Germany
  • Bremen, Germany
    • Recruiting
    • German health care register, BIPS (there may be other sites)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with nocturia due to idiopathic nocturnal polyuria or treatment for LUTS.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NOCDURNA cohort	Other: NOCDURNA Cohort; Non intervention
Lower urinary tract symptoms (LUTS) Cohort	Other: LUTS Cohort; Non intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of symptomatic hyponatraemia	Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.	Through study completion, typically 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rate of all-cause mortality	All-cause mortality was defined as death from any cause.	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.	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.	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.	Through study completion, typically 2 months
Incidence of serious adverse events of MACE and VTE in Sweden		Through study completion, typically 2 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Nocturia; NOCDURNA; Post-authorisation Safety Study
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 000248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not possible due to GDPR and other laws.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No