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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00529594
First received: September 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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


Condition Intervention
Proliferative Diabetic Retinopathy
 Drug: placebo (Control Group)
Drug: Etoricoxib (Treatment Group)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

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

Enrollment: 44
Study Start Date: August 2006
Study Completion Date: November 2006
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00529594     History of Changes
Other Study ID Numbers: 519/06
Study First Received: September 13, 2007
Last Updated: September 13, 2007
Health Authority: Brazil: Ministry of Health

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 19, 2013