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

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ClinicalTrials.gov Identifier: NCT02830178
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease
Hemorrhage, Gastrointestinal Myocardial Infarction Stroke Kidney Diseases

Study Type : Observational
Actual Enrollment : 144337 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Any Paracetamol
Participants with age 18 and over who received a first prescription of single-ingredient paracetamol or ibuprofen in 2012 will be enrolled. Their status with respect to prior gastrointestinal bleeding, myocardial infarction, stroke, or kidney disease will be assessed based on the presence or absence of a diagnosis in the 2 years prior to the index date. This observational study will evaluate whether new users of paracetamol have a higher prevalence of certain conditions (gastrointestinal bleeding, myocardial infarction, stroke or kidney disease) in their history when compared to new users of ibuprofen, propensity scores and outcome models.
Ibuprofen
Participants with age 18 and over who received a first prescription of single-ingredient ibuprofen in 2012 will be enrolled. Their status with respect to prior gastrointestinal bleeding, myocardial infarction, stroke, or kidney disease will be assessed based on the presence or absence of a diagnosis in the 2 years prior to the index date. This observational study will evaluate whether new users of paracetamol have a higher prevalence of certain conditions (gastrointestinal bleeding, myocardial infarction, stroke or kidney disease) in their history when compared to new users of ibuprofen, propensity scores and outcome models.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is a cohort of participants 18 and over who received a first prescription of single-ingredient paracetamol or ibuprofen in 2012.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830178


Locations
United States, New Jersey
Raritan, New Jersey, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02830178     History of Changes
Other Study ID Numbers: RRA-16387
RRA-16387 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Infarction
Kidney Diseases
Myocardial Infarction
Hemorrhage
Gastrointestinal Hemorrhage
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ibuprofen
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics