Status: Planned First registered on: 29/10/2019
Last updated on: 29/10/2019
1. Study identification
EU PAS Register NumberEUPAS32021
Official titleChanges in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine
Study title acronymAlternatives to codeine
Study typeObservational study
Brief description of the studyEurope-wide risk minimisation measures (RMMs) were introduced for the use of codeine for the treatment of pain relief in children in June 2013 to minimise the risk of serious adverse events. In April 2015, similar RMMs were also introduced for the use of codeine in the treatment of cough or cold in paediatric patients. This is a drug utilisation study in a cohort of patients under 18 years of age. The study has the following objectives: 1. To assess whether the codeine referrals for the treatment of pain and cough or cold in patients below 18 years of age were temporally associated with statistically significant changes in prescribing of alternative analgesics, antitussives or cold medicines in this patient population. 2. To describe prescribing trends for codeine and alternative analgesics and antitussives over time in patients below 18 years of age by evaluating the total number of children with a prescription and the total number of prescriptions of codeine and selected alternative analgesics and antitussives per time period: 2.1. In relation to all children in the database during the same time period. 2.2. Stratified by age group (0-11 years and 12-17 years) and gender.
Was this study requested by a regulator?No
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 applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameEMA
Centre locationAmsterdam
Details of (Primary) lead investigator
Title Mr
Last name Nogueras Zondag
First name Daniel
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

AEMPS
ANSM, France
The Norwegian Medicines Agency, Norway
Countries in which this study is being conducted
International study

France
Germany
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/01/2019
Start date of data collection01/10/2019
Start date of data analysis01/11/2019
Date of interim report, if expected
Date of final study report01/02/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Nogueras Zondag
First name Daniel
Address line 1Domenico Scarlattilaan 6
Address line 2 
Address line 3 
CityAmsterdam 
Postcode1083 HS 
CountryNetherlands
Phone number (incl. country code)31652045653 
Alternative phone number 
Fax number (incl. country code) 
Email address danielantonio.nogueraszondag@ema.europa.eu
Public Enquiries
Title Mr 
Last name Nogueras Zondag 
First name Daniel 
Address line 1Domenico Scarlattilaan 6 
Address line 2 
Address line 3 
CityAmsterdam 
Postcode1083 HS 
CountryNetherlands 
Phone number (incl. country code)31652045653 
Alternative phone number 
Fax number (incl. country code) 
Email address danielantonio.nogueraszondag@ema.europa.eu 
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