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

Contact details

Christian Saussine

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
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