Status: Ongoing First registered on: 04/03/2016
Last updated on: 14/02/2017
1. Study identification
EU PAS Register NumberEUPAS12669
Official titleAn Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Diagnosed with Non Cancer Pain and Treated with Opioids Chronically
Study title acronym
Study typeObservational study
Brief description of the studyThis study is designed to provide additional data to characterize the safety of naloxegol in the indicated population and within at risk vulnerable populations identified in the naloxegol RMP by describing type and frequency of identified and potential risks (including bowel perforation, acute myocardial infarction, stroke, cardiovascular-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age diagnosed with non cancer pain who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use.
Was this study requested by a regulator?Yes: EMA
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 belongsEvidera
Department/Research groupReal-World Evidence
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Dr
Last name Cid
First name Javier
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?3

IMS Health
Evidera
Countries in which this study is being conducted
International study

Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/10/2015
Start date of data collection01/12/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesKyowa Kirin100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Cid
First name Javier
Address line 1Metro Building 6th Floor
Address line 21 Butterwick 
Address line 3 
CityLondon 
PostcodeW6 8DL 
CountryUnited Kingdom
Phone number (incl. country code)34932213441 
Alternative phone number447769275683 
Fax number (incl. country code) 
Email address javier.cid@evidera.com
Public Enquiries
Title Dr 
Last name Cid 
First name Javier 
Address line 1Metro Building 6th Floor 
Address line 21 Butterwick 
Address line 3 
CityLondon 
PostcodeW6 8DL 
CountryUnited Kingdom 
Phone number (incl. country code)34932213441 
Alternative phone number4407769275683 
Fax number (incl. country code) 
Email address javier.cid@evidera.com 
Top