Status: Planned First registered on: 04/09/2015
Last updated on: 06/02/2020
1. Study identification
EU PAS Register NumberEUPAS10888
Official titleNon-interventional study with Binosto 70 mg effervescent tablets once weekly investigating gastro-intestinal events and medication errors
Study title acronymGastro-PASS
Study typeObservational study
Brief description of the studyBinosto (effervescent alendronate) has been developed with the aim of further reducing the risk of esophageal irritation, incl. the risk of tablet adhesion to the esophagus wall. In addition it is the aim to provide a convenient dosage form that would ensure better compliance across the patient population. The safety profile of Binosto will be evaluated in a real-life setting. The present study will investigate the upper gastrointestinal adverse events and medication errors associated with once weekly administration of Binosto.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
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?20
Countries in which this study is being conducted
International study

Italy
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/07/2014
Start date of data collection30/06/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report31/07/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEffRx Pharmaceuticals SA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
Address line 1The Euston Office
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom
Phone number (incl. country code)442035744617 
Alternative phone number442033977497 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) 
First name Nawab 
Address line 1The Euston Office 
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom 
Phone number (incl. country code)442035744617 
Alternative phone number442033977497 
Fax number (incl. country code) 
Top