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Status: Finalised

First registered on: 30/05/2018

Last updated on: 16/02/2020

1. Study identification

EU PAS Register NumberEUPAS24089

Official titleImpact of EU label changes for systemic diclofenac products: post-referral prescribing trends

Study title acronym

Study typeObservational study

Brief description of the studyTo evaluate the impact of the risk minimisation measures implemented in 2013 to manage the cardiovascular risks of systemic diclofenac containing medicinal products authorised in the European Union (EU) in clinical practice

Was this study requested by a regulator?Yes: EMA

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 to which the investigator belongsMEMO

Department/Research groupMedicines Monitoring Unit

Organisation/affiliationUniversity of Dundee

Website/Homepagehttps://www.memoresearch.com

Details of (Primary) lead investigator

Title Professor

Last name MacDonald

First name Thomas

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Multiple centres

In total how many centres are involved in this Study?5

PHARMO Institute

UCL School of Pharmacy

NHS National Services Scotland, Glasgow, UK

PHARMO Institute for Drug Outcomes Research, Netherlands

University College, London

University of Southern Denmark, Denmark

University of Strathclyde, Glasgow

Countries in which this study is being conducted

International study

Denmark

Netherlands

United Kingdom

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed06/09/201706/09/2017

Start date of data collection01/07/201801/07/2018

Start date of data analysis

Date of interim report, if expected

Date of final study report06/01/201906/01/2019

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 body

Research councils

EU funding schemeEuropean Medicines Agency100

5. Contact details for enquiries

Scientific Enquiries

Title Professor

Last name MacDonald

First name Thomas

Address line 1Medicines Monitoring Unit/Hypertension Research Centre

Address line 2Ninewells Hospital & Medical School

Address line 3Mailbox 2, Level 7

CityDundee

PostcodeDD1 9 SY

CountryUnited Kingdom

Phone number (incl. country code)441382383119

Alternative phone number441382383232

Fax number (incl. country code)441382643204

Email address t.m.macdonald@dundee.ac.uk

Public Enquiries

Title Professor

Last name MacDonald

First name Thomas

Address line 1Medicines Monitoring Unit/Hypertension Research Centre

Address line 2Ninewells Hospital & Medical School

Address line 3Mailbox 2, Level 7

CityDundee

PostcodeDD1 9 SY

CountryUnited Kingdom

Phone number (incl. country code)441382383119

Alternative phone number441382383232

Fax number (incl. country code)441382643204

Email address t.m.macdonald@dundee.ac.uk

11. Scope of the study

What is the scope of the study?

Drug utilisation study

Effectiveness evaluation

Primary scope : Drug utilisation study

12. Main objective(s)

What is the main objective of the study?

Three main objectives as follows: To determine prescription patterns of diclofenac containing products. To determine prescribers compliance with cardiovascular contraindications and risk factors. To determine prescription patterns of alternative medicines prescribed in patient where diclofenac has previously been prescribed.

Are there primary outcomes?No

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Drug utilisation study

Time series analysis

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

In order to determine prescription patterns of diclofenac containing product, prescribers' compliance with cardiovascular contra-indications and risk factors and prescription patterns of alternative medicines prescribed in patients where diclofenac has previously been prescribed, the proposed primary analysis will use interrupted time series regression to fit time trends to each series of time period data (based on quarterly time periods)for each country.Using regression modelling we will evaluate:(I)the baseline slope before the regulatory intervention time point (ii)the change in slope from the baseline trend to the post-intervention trend; and (iii) the immediate change associated with the regulatory intervention time point. The choice of analytical technique will be decided based on visual inspection of the data. The analysis will be done by data source initially, and only pooled if the statistical models do not differ significantly between data sources.