Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation

September 13, 2007 updated by: University of Sao Paulo
The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To do so we compare two group of patients, randomized 1:1, one use the medication(etoricoxib) and other use placebo and they quantify the pain using the Pain visual analogue scale

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-000
        • Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diabetic retinopathy that needs laser photocoagulation for the first time

Exclusion Criteria:

  • Younger than 17
  • Signs and symptoms of liver dysfunction or abnormal liver function tests
  • Gastrointestinal diseases
  • Pregnant women
  • Edema
  • Pre-existing cardiac insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control Group
Patients who received placebo
Drug: placebo (Control Group)
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
ACTIVE_COMPARATOR: Treatment Group
Patients who received etoricoxib 120 mg
Drug: Etoricoxib (Treatment Group)
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
Other Names:
  • Etoricoxib 120mg is Arcoxia 120mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The group taking the etoricoxib feel less pain then the group taking placebo
Time Frame: After each laser session
After each laser session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Vinicius P Nascimento, MD, Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (ESTIMATE)

September 14, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2007

Last Update Submitted That Met QC Criteria

September 13, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 519/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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