A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications

The Purpose of this study is to examine whether evidence of channeling exists by analyzing within a cohort of participants with first prescriptions of single-ingredient paracetamol or ibuprofen (or both) whether participants with paracetamol were more likely to have an ibuprofen-related contraindication.

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Key information

Conditions

Hemorrhage, Gastrointestinal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Hemorrhage Heart Diseases Hemorrhage Infarction Ischemia Kidney Diseases Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Raritan, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Enrolled in up-to-standard practices (practices that have been qualified for research purposes by the Clinical Practice Research Datalink [CPRD] administrators) in the CPRD
Received a first prescription for paracetamol or a first prescription for ibuprofen in 2012
Were age 18 or older in the date of their qualifying prescription in 2012

Exclusion criteria

Who received a prescription for paracetamol or ibuprofen in the 6 months prior to their qualifying prescription in 2012
Who received a prescription for any acetaminophen- or ibuprofen-containing combination products in the 6 months prior to the qualifying prescription in 2012

Treatment and study plan

Primary outcomes

Evidence of Channeling as Measured by an Odds-ratio Different From 1.0 for Contraindications to Ibuprofen Comparing Paracetamol and Ibuprofen Groups

Time frame: up to 7 months

Participants receiving first prescriptions of single-ingredient paracetamol or ibuprofen will be assessed to analyze whether participants with paracetamol were more likely to have had an ibuprofen-related contraindication than participants with ibuprofen.

Secondary outcomes

Propensity Score Model

Time frame: up to 7 months

The potential to control for channeling bias will be examined. It will also assess whether there will be sufficient overlap in propensity scores to allow for adequate adjustment to control for bias due to channeling. The propensity score is the estimated probability of receiving a treatment (paracetamol), based on the available data, ranges from 0 to 1. The higher the score, the more likely to be treated with paracetamol.
Extent of Bias as Measured by an Odds-ratio Different From 1.0 for the Covariate Indicating Exposure to Paracetamol or Ibuprofen in the Negative Control Outcome Models

Time frame: up to 7 months

Relative risks for paracetamol versus ibuprofen for the 31 negative control outcomes should be 1.0 if there is no bias. A series of models with increasing numbers of covariates will be fit to measure the extent to which covariates can diminish the impact of bias.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jul 12, 2016
Registry last updated: Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed