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Over 1 million records reviewed to check safety of nighttime urination drug

NCT ID NCT04740645

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at medical records from Denmark, Sweden, and Germany to see how safe NOCDURNA is for people who wake up often at night to urinate due to a condition called nocturnal polyuria. Researchers tracked serious side effects like low sodium levels in the blood. The study did not test if the drug works, only monitored safety in real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,099,551 people

The number who actually took part.

Started

Jul 2021

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Usage of NOCDURNA recorded as dispensations in adults or usage of drugs for LUTS. Exclusion Criteria: * Multiple dispensations of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.

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Conditions

The condition(s) this trial relates to.

Drug-Related Side Effects and Adverse Reactions Nocturia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Danish Health Care Registry

    Copenhagen, Denmark

  • German Health Care Register

    Bremen, Germany

  • Socialstryrelsen

    Stockholm, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.