Study identification

PURI

https://redirect.ema.europa.eu/resource/35646

EU PAS number

EUPAS23109

Study ID

35646

Official title and acronym

Safety Profile of Extended Release (650 mg) Acetaminophen Products in the United States: Non-Interventional Post-authorization Safety Study of the National Poison Data System and Food and Drug Administration Adverse Event Reporting System Databases

DARWIN EU® study

No

Study countries

United States

Study description

The research question addressed by this study is: what is the safetyprofile of extended release acetaminophen use among adolescents andadults (aged ≥12 years) in the United States (US)? This study aims todescribe the safety profile of extended release acetaminophen in the USthrough evaluation of two independent surveillance data systems, theNational Poison Data System (NPDS) and Food and DrugAdministration (FDA) Adverse Event Reporting System (FAERS).Specifically, the study aims to characterize adolescent and adult (aged ≥12 years) exposures to extended release acetaminophen products, describe and compare reporting rates for extended and immediate release acetaminophen products, compare outcomes of extended and immediate release acetaminophen product exposures among US adolescents and adults (age ≥12 years).

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Richard Dart

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

Johnson and Jonson Consumer Inc.
Study protocol
Initial protocol

NI-PASS Protocol APAP ER 2018-03-27 CONNECT

English (260.58 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