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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02651363

Enrollment

374

Registered

2016-01-11

Start date

2016-03-31

Completion date

2016-09-30

Last updated

2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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®

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Observed AEs 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	Risk factors: medical history, concomitant diseases and concomitant treatment
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

Countries

Peru

Outcome results