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. (NOCDURNA PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48154
• EU PAS number:
  EUPAS38365
• Study ID:
  48154
• Official title and acronym:
  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. (NOCDURNA PASS)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Sweden
• Study status:
  Ongoing

Research institution and networks

Institutions

Ferring Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual: 30/11/2020

Study start date

Planned: 01/07/2021

Actual: 01/07/2021

Data analysis start date

Planned: 01/08/2021

Date of interim report, if expected

Planned: 31/12/2021

Date of final study report

Planned: 11/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ferring Pharmaceuticals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)