Status: Finalised First registered on: 05/11/2021
Last updated on: 22/11/2021
1. Study identification
EU PAS Register NumberEUPAS43996
Official titleELMIRON: 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 title acronym
Study typeObservational study
Brief description of the studyThe 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).
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableID RCB: 2021-A00802-39
2. Research centres and Investigator details
Coordinating study entity
Centre nameNouvel Hôpital Civil
Centre locationStrasbourg cedex
Details of (Primary) lead investigator
Title Professor
Last name Saussine
First name Christian
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/03/202115/07/2021
Start date of data collection30/06/202115/09/2021
Start date of data analysis31/12/202304/11/2021
Date of interim report, if expected31/05/202204/11/2021
Date of final study report31/03/202404/11/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesbene-Arzneimittel GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Waltenberger
First name Constanze
Address line 1Herterichstr. 1-3
Address line 2 
Address line 3 
CityMunich 
Postcode 
CountryGermany
Phone number (incl. country code)498974987232 
Alternative phone number 
Fax number (incl. country code) 
Email address contact@bene-gmbh.de
Public Enquiries
Title Ms 
Last name Glück 
First name Sandra 
Address line 1Herterichstr. 1-3 
Address line 2 
Address line 3 
CityMunich 
Postcode 
CountryGermany 
Phone number (incl. country code)498974987231 
Alternative phone number 
Fax number (incl. country code) 
Email address contact@bene-gmbh.de 
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