Status: Finalised First registered on: 06/06/2017
Last updated on: 28/02/2019
1. Study identification
EU PAS Register NumberEUPAS19445
Official titleA drug utilisation study of Rifaxamin-α 550mg
Study title acronym
Study typeObservational study
Brief description of the studyA drug utilisation study conducted in CPRD GOLD to understand the dosing, the formulation, the indications and the patient demographics associated with rifaximin-α 550mg tablets across the UK following launch in January 2013.
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 belongsCPRD
Department/Research group
Organisation/affiliationClinical Practice Research Datalink
Website/Homepagewww.cprd.com
Details of (Primary) lead investigator
Title Ms
Last name Campbell
First name Jennifer
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/12/201418/12/2014
Start date of data collection21/04/201506/07/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report09/07/201518/01/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNorgine Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Amlani
First name Bharat
Address line 1Norgine House
Address line 2Widewater Place 
Address line 3Moorhall Road 
CityUxbridge 
PostcodeUB9 6NS 
CountryUnited Kingdom
Phone number (incl. country code)44-1895-826622 
Alternative phone number 
Fax number (incl. country code) 
Email address bamlani@norgine.com
Public Enquiries
Title Mr 
Last name Amlani 
First name Bharat 
Address line 1Norgine House 
Address line 2Widewater Place 
Address line 3Moorhall Road 
CityUxbridge 
PostcodeUB9 6NS 
CountryUnited Kingdom 
Phone number (incl. country code)44-1895-826622 
Alternative phone number 
Fax number (incl. country code) 
Email address bamlani@norgine.com 
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