NCT00529594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

September 14, 2007

Status Verified

March 1, 2007

First QC Date

September 13, 2007

Last Update Submit

September 13, 2007

Conditions

Proliferative Diabetic Retinopathy

Keywords

Laser PhotocoagulationPain relief

Outcome Measures

Primary Outcomes (1)

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

    After each laser session

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients who received placebo

Drug: placebo (Control Group)

Treatment Group

ACTIVE COMPARATOR

Patients who received etoricoxib 120 mg

Drug: Etoricoxib (Treatment Group)

Interventions

placebo (Control Group)DRUG

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

Control Group
Etoricoxib (Treatment Group)DRUG

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

Also known as: Etoricoxib 120mg is Arcoxia 120mg
Treatment Group

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diabetic retinopathy that needs laser photocoagulation for the first time

You may not qualify if:

  • Younger than 17
  • Signs and symptoms of liver dysfunction or abnormal liver function tests
  • Gastrointestinal diseases
  • Pregnant women
  • Edema
  • Pre-existing cardiac insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Interventions

Control GroupsEtoricoxib

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsSulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Vinicius P Nascimento, MD

    Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

August 1, 2006

Study Completion

November 1, 2006

Last Updated

September 14, 2007

Record last verified: 2007-03

Locations

BR(1)