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Clinical Trials/NCT02651363
NCT02651363CompletedNot Applicable

Incidence of Adverse Events, Risk Factors, and Drug Utilization Factors Related to Treatment With Diclofenac 25 MG/Paracetamol 500 MG and Diclofenac 50 MG/Paracetamol 500 MG in Patients From Metropolitan Lima

Bristol-Myers Squibb1 site in 1 country374 target enrollmentStarted: March 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
374
Locations
1
Primary Endpoint
Incidence rate of adverse events (AEs) in patients receiving treatment with Dolocordralan Extra 25 and and Dolocordralan Extra Forte in patients from Metropolitan Lima records
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to collect adverse events and identify risk factors in patients that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who are prescribed Dolocordralan Extra 25 and Dolocordralan Extra Forte at any of the participating clinics
  • •Patients who sign the informed consent form
  • •Patients who agree to comply with the study procedures

Exclusion Criteria

  • •Please see the protocol for further information on exclusion criteria

Outcomes

Primary Outcomes

Incidence rate of adverse events (AEs) in patients receiving treatment with Dolocordralan Extra 25 and and Dolocordralan Extra Forte in patients from Metropolitan Lima records

Time Frame: Approximately 13 months

Ongoing events will be followed up until event resolution

Secondary Outcomes

  • Observed AEs in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records(Approximately 13 months)
  • Drug utilization factors in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records(Approximately 13 months)
  • Risk factors in patients experiencing adverse events while receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records(Approximately 13 months)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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