Study identification

PURI

https://redirect.ema.europa.eu/resource/18103

EU PAS number

EUPAS10649

Study ID

18103

Official title and acronym

Usage Patterns of Selected Systemic NSAIDs (Including Diclofenac): A Retrospective Cohort Study

DARWIN EU® study

No

Study countries

United Kingdom
United States

Study description

This will be a non-interventional, descriptive, retrospective drug utilization study, using a cohort design, of users of selected systemic NSAIDs. The objective is to describe the usage pattern of selected systemic NSAIDs including diclofenac using the most recent information available from select population-based health care automated databases in Europe and North America. The study aims to accomplish the following:• Describe demographic characteristics, specific comorbidities, selected comedications, and selected potential indications for use among patients treated with selected systemic NSAIDs (including diclofenac)• Describe treatment patterns, including dose, duration of treatment, and switching patterns, among patients treated with selected systemic NSAIDs (including diclofenac)

Study status

Finalised
Research institution and networks

Institutions

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma
Study protocol
Initial protocol

CVOL458A2001_v00_final protocol_redacted

English (453.88 KB - PDF)View document
Updated protocol

vol458a2001--protocol-or-amendment_redacted

English (921.81 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable