Adverse Drug EventNCT04740645
NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden
An observational study of Adverse Drug Event, run by Ferring Pharmaceuticals at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- NOCDURNA Cohort and LUTS Cohort
- How many people
- 1,099,551 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 13 Jul 2021to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with usage of NOCDURNA identified as dispensations/prescriptions or dispensations/prescription of drugs for LUTS
Who may be able to join
- Usage of NOCDURNA recorded as dispensations in adults or usage of drugs for LUTS.
Who cannot join
- Multiple dispensations of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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
- Being tested
- NOCDURNA Cohort, LUTS Cohort
- Keywords
- Nocturia, NOCDURNA, Post-authorisation Safety Study
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOCDURNA CohortOther
Non intervention
LUTS CohortOther
Non intervention
| Study group | Role | What they receive |
|---|---|---|
| NOCDURNA cohort | Not described Receives: Other: NOCDURNA Cohort | |
| Lower urinary tract symptoms (LUTS) Cohort | Not described Receives: Other: LUTS Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of symptomatic hyponatraemia
Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.
Measured: Through study completion, typically 2 months
Secondary outcomes (7)
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.
Measured: 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).
Measured: Through study completion, typically 2 months
Rate of all-cause mortality
All-cause mortality was defined as death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, typically 2 months
Incidence of serious adverse events of MACE and VTE in Sweden
Measured: Through study completion, typically 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start13 Jul 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,099,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740645
- Sponsor's protocol ID
- 000248
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41281576
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04740645
- Acronym / sponsor ID
- 000248
- Conditions
- Adverse Drug Event
- Keywords
- Nocturia, NOCDURNA, Post-authorisation Safety Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,099,551 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOCDURNA cohort | – | Other: NOCDURNA Cohort |
| Lower urinary tract symptoms (LUTS) Cohort | – | Other: LUTS Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with usage of NOCDURNA identified as dispensations/prescriptions or dispensations/prescription of drugs for LUTS
Key inclusion criteria (1 listed)
- Usage of NOCDURNA recorded as dispensations in adults or usage of drugs for LUTS.
Key exclusion criteria (1 listed)
- Multiple dispensations of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOCDURNA CohortNon intervention | Other | NOCDURNA cohort |
| LUTS CohortNon intervention | Other | Lower urinary tract symptoms (LUTS) Cohort |
Primary outcome
Incidence rate of symptomatic hyponatraemia
Time frame: Through study completion, typically 2 months
Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.
7 secondary outcomes
Incidence rate of hyponatraemia requiring hospital intensive care
Time frame: Through study completion, typically 2 months
Incidence and severity of clinically significant hyponatraemia
Time frame: Through study completion, typically 2 months
Rate of all-cause mortality
Time frame: Through study completion, typically 2 months
Incidence rate of major adverse cardiovascular events (MACE)
Time frame: Through study completion, typically 2 months
Incidence rate of major venous thromboembolic events (VTEs)
Time frame: Through study completion, typically 2 months
Incidence rate acute exacerbation of congestive heart failure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 41281576Johansson 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.
- DOI: 10.1016/j.gloepi.2025.100228Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Event, run by Ferring Pharmaceuticals at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of symptomatic hyponatraemia (time frame: Through study completion, typically 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.