Hemorrhage, GastrointestinalNCT02830178
A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
An observational study of Hemorrhage, Gastrointestinal and Myocardial Infarction, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Gastrointestinal, Myocardial Infarction, Stroke
- How many people
- 144,337 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Medical subject headings
- Gastrointestinal Hemorrhage, Myocardial Infarction, Stroke, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Channeling as Measured by an Odds-ratio Different From 1.0 for Contraindications to Ibuprofen Comparing Paracetamol and Ibuprofen Groups
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.
Measured: up to 7 months
Secondary outcomes (2)
Propensity Score Model
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.
Measured: up to 7 months
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
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.
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage, GastrointestinalStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144,337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830178
- Sponsor's protocol ID
- RRA-16387
- Other IDs
- RRA-16387
- Status last verified
- Oct 2016
- First submitted
- 7 Jun 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinstein RB, Ryan P, Berlin JA, Matcho A, Schuemie M, Swerdel J, Patel K, Fife D. Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications. Drug Saf. 2017 Dec;40(12):1279-1292. doi: 10.1007/s40264-017-0581-7.
PubMed 28780741
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
- ClinicalTrials.gov ID
- NCT02830178
- Acronym / sponsor ID
- RRA-16387
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144,337 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Propensity Score Model
Time frame: up to 7 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 28780741Weinstein RB, Ryan P, Berlin JA, Matcho A, Schuemie M, Swerdel J, Patel K, Fife D. Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications. Drug Saf. 2017 Dec;40(12):1279-1292. doi: 10.1007/s40264-017-0581-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, Gastrointestinal and Myocardial Infarction, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.