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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

June 7, 2016
July 12, 2016
October 11, 2016
January 2016
September 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02830178 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The study population is a cohort of participants 18 and over who received a first prescription of single-ingredient paracetamol or ibuprofen in 2012.
  • Hemorrhage, Gastrointestinal
  • Myocardial Infarction
  • Stroke
  • Kidney Diseases
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144337
120000
September 2016
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02830178
RRA-16387
RRA-16387 ( Other Identifier: Janssen Research & Development, LLC )
No
Not Provided
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
October 2016