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

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
placebo (Control Group)
Etoricoxib (Treatment Group)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Laser Photocoagulation, Pain relief

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group

Treatment Group

Arm Description

Patients who received placebo

Patients who received etoricoxib 120 mg

Outcomes

Primary Outcome Measures

The group taking the etoricoxib feel less pain then the group taking placebo

Secondary Outcome Measures

Full Information

First Posted
September 13, 2007
Last Updated
September 13, 2007
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00529594
Brief Title
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Official Title
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Laser Photocoagulation, Pain relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients who received placebo
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
Patients who received etoricoxib 120 mg
Intervention Type
Drug
Intervention Name(s)
placebo (Control Group)
Intervention Description
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
Intervention Type
Drug
Intervention Name(s)
Etoricoxib (Treatment Group)
Other Intervention Name(s)
Etoricoxib 120mg is Arcoxia 120mg
Intervention Description
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
Primary Outcome Measure Information:
Title
The group taking the etoricoxib feel less pain then the group taking placebo
Time Frame
After each laser session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinicius P Nascimento, MD
Organizational Affiliation
Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

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

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