ELMIRON: Observational Study for the Characterisation of Treatment Practice, Patients, and Symptom Load of Oral Pentosane Polysulfate Sodium for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44360
• EU PAS number:
  EUPAS43996
• Study ID:
  44360
• Official title and acronym:
  ELMIRON: Observational Study for the Characterisation of Treatment Practice, Patients, and Symptom Load of Oral Pentosane Polysulfate Sodium for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The objective of this study is to characterise the patients treated with elmiron® and how elmiron® is used (e.g. age, diagnostic criteria for prescription, dosage, duration of treatment, reasons for stopping treatment, and co-treatment).
• Study status:
  Finalised

Research institution and networks

Institutions

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/03/2021

Actual: 15/07/2021

Study start date

Planned: 30/06/2021

Actual: 15/09/2021

Data analysis start date

Planned: 31/12/2023

Actual: 04/11/2021

Date of interim report, if expected

Planned: 31/05/2022

Actual: 04/11/2021

Date of final study report

Planned: 31/03/2024

Actual: 04/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

bene-Arzneimittel GmbH

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ID RCB: 2021-A00802-39