Proliferative Diabetic RetinopathyNCT00529594
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
A study testing Etoricoxib (Treatment Group) in people with Proliferative Diabetic Retinopathy, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Etoricoxib (Treatment Group)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diabetic retinopathy that needs laser photocoagulation for the first time
Who cannot join
- Younger than 17
- Signs and symptoms of liver dysfunction or abnormal liver function tests
- Gastrointestinal diseases
- Pregnant women
- Edema
- Pre-existing cardiac insufficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
About this study
The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.
Read the 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
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- placebo (Control Group), Etoricoxib (Treatment Group)
- Keywords
- Laser Photocoagulation, Pain relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo (Control Group)Drug
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
Etoricoxib (Treatment Group)Drug
Also called Etoricoxib 120mg is Arcoxia 120mg
Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients who received placebo Receives: Drug: placebo (Control Group) |
| Treatment Group | Active comparator | Patients who received etoricoxib 120 mg Receives: Drug: Etoricoxib (Treatment Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The group taking the etoricoxib feel less pain then the group taking placebo
Measured: After each laser session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startAug 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Vinicius P Nascimento, MD, Principal investigator, Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529594
- Sponsor's protocol ID
- 519/06
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2007
- Last updated
- 14 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
- ClinicalTrials.gov ID
- NCT00529594
- Acronym / sponsor ID
- 519/06
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Laser Photocoagulation, Pain relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: placebo (Control Group)Patients who received placebo |
| Treatment Group | Active comparator | Drug: Etoricoxib (Treatment Group)Patients who received etoricoxib 120 mg |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diabetic retinopathy that needs laser photocoagulation for the first time
Key exclusion criteria (6 listed)
- Younger than 17
- Signs and symptoms of liver dysfunction or abnormal liver function tests
- Gastrointestinal diseases
- Pregnant women
- Edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo (Control Group)Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation | Drug | Control Group |
| Etoricoxib (Treatment Group)Also: Etoricoxib 120mg is Arcoxia 120mgBoth medication have been given to the patients in both groups 1 hour prior the laser photocoagulation | Drug | Treatment Group |
Primary outcome
The group taking the etoricoxib feel less pain then the group taking placebo
Time frame: After each laser session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinicius P Nascimento, MD principal investigator
Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etoricoxib (Treatment Group) in people with Proliferative Diabetic Retinopathy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The group taking the etoricoxib feel less pain then the group taking placebo (time frame: After each laser session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2007; AzTrials last refreshed its copy on 8 Nov 2026.