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

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ClinicalTrials.gov Identifier: NCT02651363
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
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®

Condition or disease
Pain

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Study Type : Observational
Actual Enrollment : 374 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Diclofenac

Group/Cohort
Patients treated with Dolocordralan



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Observed AEs in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records [ Time Frame: Approximately 13 months ]
  2. Risk factors in patients experiencing adverse events while receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records [ Time Frame: Approximately 13 months ]
    Risk factors: medical history, concomitant diseases and concomitant treatment

  3. Drug utilization factors in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records [ Time Frame: Approximately 13 months ]
    Drug utilization factors: Dosing frequency, intake conditions, storage, and concomitant medications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 18 years of age or and older from 6 medical centers from Metropolitan Lima, Peru who received at least one dose of Dolocordralan Extra 25 or Dolocordralan Extra Forte according to product label indications will be included in this study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651363


Locations
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Peru
Local Institution
San Miguel, Lima, Peru
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02651363     History of Changes
Other Study ID Numbers: CN003-001
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Acetaminophen
Diclofenac
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action