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NCT02651363 Clinical Trial

Diclofenac 25mg/Paracetamol 500 mg and Diclofenac 50 mg/Paracetamol 500 mg for Patients With Pain

Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02651363
Other study ID # CN003-001
Secondary ID
Status Completed
Phase N/A
First received December 10, 2015
Last updated April 17, 2017
Start date March 2016
Est. completion date September 2016

Study information
Verified date April 2017
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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®

Recruitment information / eligibility
Status Completed
Enrollment 374
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Peru Local Institution San Miguel Lima

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Peru, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Ongoing events will be followed up until event resolution Approximately 13 months
Secondary Observed AEs in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records Approximately 13 months
Secondary Risk factors in patients experiencing adverse events while receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records Risk factors: medical history, concomitant diseases and concomitant treatment Approximately 13 months
Secondary Drug utilization factors in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records Drug utilization factors: Dosing frequency, intake conditions, storage, and concomitant medications Approximately 13 months
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