Diabetic RetinopathyPhase 4NCT01382498
Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
A Phase 4 study testing Calcium dobesilate (Doxium) in people with Diabetic Retinopathy, run by Tabriz University at 1 site in Iran.
Trial summary
Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Calcium dobesilate (Doxium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BS 120-200 mg/dl
- Age 40-70
- Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)
- type II diabetes
- no history of doxium consumption
Who cannot join
- Allergy to doxium
- incidence of active hepatic disease or rising of hepatic enzymes during the intervention
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tabriz University of Medical Sciences
Tabriz, Eastern Azerbayjan, 5137874976
About this study
Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.
- Conditions
- Diabetic Retinopathy
- Being tested
- Calcium dobesilate (Doxium), Placebo drug
- Keywords
- Endothelin-1 high sensitivity CRP
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium dobesilate (Doxium)Drug
500 mg, Tablet, Daily, 3 months
Placebo drugDrug
Similar to the that of the Experimental arm, Daily, Three months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets will be administered to the patients in Placebo arms daily for three months. Receives: Drug: Placebo drug |
| Calcium dobesilate | Experimental | Calcium dobesilate as 500 mg tablets will be administered once to the patients daily. Receives: Drug: Calcium dobesilate (Doxium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
high sensitivity CRP and Endothelin-1 serum levels
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startNov 2009
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382498
- Sponsor's protocol ID
- 88-8
- Status last verified
- Apr 2011
- First submitted
- 21 May 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01382498
- Acronym / sponsor ID
- 88-8
- Conditions
- Diabetic Retinopathy
- Keywords
- Endothelin-1 high sensitivity CRP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (estimated)
- First posted
- 27 Jun 2011 (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.
Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo drugPlacebo tablets will be administered to the patients in Placebo arms daily for three months. |
| Calcium dobesilate | Experimental | Drug: Calcium dobesilate (Doxium)Calcium dobesilate as 500 mg tablets will be administered once to the patients daily. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BS 120-200 mg/dl
- Age 40-70
- Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)
- type II diabetes
- no history of doxium consumption
Key exclusion criteria (2 listed)
- Allergy to doxium
- incidence of active hepatic disease or rising of hepatic enzymes during the intervention
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 |
|---|---|---|
| Calcium dobesilate (Doxium)500 mg, Tablet, Daily, 3 months | Drug | Calcium dobesilate |
| Placebo drugSimilar to the that of the Experimental arm, Daily, Three months | Drug | Placebo |
Primary outcome
high sensitivity CRP and Endothelin-1 serum levels
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium dobesilate (Doxium) in people with Diabetic Retinopathy, run by Tabriz University at 1 site in Iran.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. 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 Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
high sensitivity CRP and Endothelin-1 serum levels (time frame: 3 month). 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 27 Jun 2011.