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

NCT ID: NCT00529594

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control Group

Patients who received placebo

Group Type PLACEBO_COMPARATOR

placebo (Control Group)

Intervention Type DRUG

Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation

Treatment Group

Patients who received etoricoxib 120 mg

Group Type ACTIVE_COMPARATOR

Etoricoxib (Treatment Group)

Intervention Type DRUG

Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation

Interventions

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placebo (Control Group)

Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation

Intervention Type DRUG

Etoricoxib (Treatment Group)

Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation

Intervention Type DRUG

Other Intervention Names

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Etoricoxib 120mg is Arcoxia 120mg

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Vinicius P Nascimento, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo

Locations

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Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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519/06

Identifier Type: -

Identifier Source: org_study_id