Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Re... | NCT00529594

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

NCT00529594

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Sep 14, 2007Estimated

Enrollment

44Actual

Phase

Not Applicable

Conditions

Proliferative Diabetic Retinopathy

Interventions

placebo (Control Group)
Etoricoxib (Treatment Group)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Sep 13, 2007

First Submission Date that Met QC Criteria

Sep 13, 2007

First Posted Date

Sep 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2007

Last Update Posted Date

Sep 14, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
placebo (Control Group)	Drug	Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation	Control Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The group taking the etoricoxib feel less pain then the group taking placebo		After each laser session

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vinicius P Nascimento, MD	Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo		São Paulo	São Paulo	05403-000	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups
D000077613	Etoricoxib

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

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Browse Branches

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