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

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ClinicalTrials.gov Identifier: NCT00529594
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 14, 2007
Sponsor:
Information provided by:
University of Sao Paulo

Brief Summary:
The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: placebo (Control Group) Drug: Etoricoxib (Treatment Group) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Study Start Date : August 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Etoricoxib 120mg is Arcoxia 120mg



Primary Outcome Measures :
  1. The group taking the etoricoxib feel less pain then the group taking placebo [ Time Frame: After each laser session ]


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00529594


Locations
Brazil
Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Vinicius P Nascimento, MD Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo

ClinicalTrials.gov Identifier: NCT00529594     History of Changes
Other Study ID Numbers: 519/06
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: September 14, 2007
Last Verified: March 2007

Keywords provided by University of Sao Paulo:
Laser Photocoagulation
Pain relief

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Analgesics
Etoricoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents