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

Completed

• Conditions: Pain

• Registration Number: NCT02651363
• Lead Sponsor: Bristol-Myers Squibb

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®

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-03
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

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Exclusion Criteria

• Please see the protocol for further information on exclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Approximately 13 months	Ongoing events will be followed up until event resolution

Secondary Outcome Measures

Name	Time	Method
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	Drug utilization factors: Dosing frequency, intake conditions, storage, and concomitant medications
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	Risk factors: medical history, concomitant diseases and concomitant treatment

Trial Locations

Locations (1)

Local Institution; 🇵🇪 San Miguel, Lima, Peru