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

September 13, 2007
September 13, 2007
August 2006
Not Provided
The group taking the etoricoxib feel less pain then the group taking placebo [ Time Frame: After each laser session ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation

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

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
  • Drug: placebo (Control Group)
    Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
  • 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
  • Placebo Comparator: Control Group
    Patients who received placebo
    Intervention: Drug: placebo (Control Group)
  • Active Comparator: Treatment Group
    Patients who received etoricoxib 120 mg
    Intervention: Drug: Etoricoxib (Treatment Group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2006
Not Provided

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
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00529594
519/06
No
Not Provided
University of Sao Paulo
Not Provided
Principal Investigator: Vinicius P Nascimento, MD Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo
University of Sao Paulo
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP