NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

NCT04740645 | Completed FDA Drug

• 1 other identifier: 000248
• Study Type: observational
• Target: 1,099,551
• Locations: 3 countries
• Sites: 3

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.

Conditions

Adverse Drug Event

Keywords

Nocturia; NOCDURNA; Post-authorisation Safety Study

Outcome Measures

Primary Outcomes (1)

• Incidence rate of symptomatic hyponatraemia

  Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.

  Through study completion, typically 2 months

Secondary Outcomes (7)

• Incidence rate of hyponatraemia requiring hospital intensive care

  Through study completion, typically 2 months

• Incidence and severity of clinically significant hyponatraemia

  Through study completion, typically 2 months

• Rate of all-cause mortality

  Through study completion, typically 2 months

• Incidence rate of major adverse cardiovascular events (MACE)

  Through study completion, typically 2 months

• Incidence rate of major venous thromboembolic events (VTEs)

  Through study completion, typically 2 months

Study Arms (2)

NOCDURNA cohort

Other: NOCDURNA Cohort

Lower urinary tract symptoms (LUTS) Cohort

Other: LUTS Cohort

Interventions

NOCDURNA Cohort OTHER

Non intervention

NOCDURNA cohort

LUTS Cohort OTHER

Non intervention

Lower urinary tract symptoms (LUTS) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with usage of NOCDURNA identified as dispensations/prescriptions or dispensations/prescription of drugs for LUTS

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (3)

Danish Health Care Registry

Copenhagen, Denmark

Location

German Health Care Register

Bremen, Germany

Location

Socialstryrelsen

Stockholm, Sweden

Location

Related Publications (1)

• Johansson G, Reinold J, Shapero NL, Rosell TL, Jorgensen LA, Koenen N, Frosig C, Falkenberg M, Holdrup L, Juul K. Real-life safety assessment of orally disintegrating desmopressin tablet: Incidence of diagnosed hyponatraemia and other events across three European countries. Glob Epidemiol. 2025 Oct 31;10:100228. doi: 10.1016/j.gloepi.2025.100228. eCollection 2025 Dec.

  PMID: 41281576 RESULT

Related Links

• DOI: 10.1016/j.gloepi.2025.100228

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Nocturia

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: July 13, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (1); SE (1)