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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529594
• Other study ID #: 519/06
• Status: Completed
• Phase: N/A
• First received: September 13, 2007
• Last updated: September 13, 2007
• Start date: August 2006
• Est. completion date: November 2006

Study information

• Verified date: March 2007
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy

Intervention

Drug:
• placebo (Control Group)
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
• Etoricoxib (Treatment Group)
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation

Locations

Country	Name	City	State
Brazil	Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The group taking the etoricoxib feel less pain then the group taking placebo		After each laser session