Status: Finalised
First registered on:
05/11/2021
Last updated on:
08/05/2023
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)
Public Enquiries
Title Mr
Last name Thomas
First name Goros
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)
6. Study drug(s) information
Product Nameelmiron
CountryFrance
Substance INN(s)PENTOSAN POLYSULFATE SODIUM
7. Medical conditions to be studied
Medical condition(s)Yes
Chronic interstitial cystitis
Off label use
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects100
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prescription event monitoring
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
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).
Primary objective = Characterisation of elmiron® treatment practice for the treatment of IC/BPS
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Prescription event monitoring
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
After initial visit every six months; total: a maximum of 6 visits
15. Data analysis plan
Please provide a brief summary of the analysis method
ELMIRON is a non-comparative, exploratory study not involving the formal testing of any preformulated hypotheses. Parameters are summarised by appr. key figures (number, percentage for categorical data; arithmetic mean, standard deviation, minimum, median, maximum, sample size for metric data). The Kaplan-Meier-Estimator used to model drug survival. Descriptive statistics are performed for all subjects and defined subgroups. The creation of additional subgroups is permissible. Differences between the groups are tested by the non-parametric Mann-Whitney Test and the χ² Test for significance in a purely exploratory fashion. The statistical analysis software Stata® is used for all statistical analyses.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
