A randomised study of sulindac and epalrestat in diabetic retinopathy
| ISRCTN | ISRCTN54039758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54039758 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/10/2006
- Registration date
- 12/10/2006
- Last edited
- 16/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Yukiko Hattori
Scientific
Scientific
Department of Molecular Oncology
Division of Molecular and Cellular Biology Institute on Aging and Adptation
Shinshu University School of Medicine
3-1-1 Asahi
Matsumoto
390-8621
Japan
Study information
| Study design | Interventional randomised single-blind uncontrolled parallel-assignment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RSSEDR |
| Study objectives | The primary purpose is to evaluate the effects of long term treatment with sulindac and epalrestat in diabetic retinopathy. |
| Ethics approval(s) | Institutional Review Board of Asama General Hospital, date of Approval 01/08/1997 (reference number: AGH 97-01). |
| Health condition(s) or problem(s) studied | Diabetic Retinopathy |
| Intervention | 1. The sulindac group: patients took 100 mg of sulindac twice a day 2. The epalrestat group: patients took 50 mg of epalrestat three times a day 3. The control group: patients took no additional medications |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sulindac, epalrestat |
| Primary outcome measure | 1. Seven-field stereoscopic retinal photography at baseline, and yearly intervals 2. Endpoint if they were diagnosed with proliferative diabetic retinopathy |
| Secondary outcome measures | 1. Glycosylated Hemoglobin (GHb) values determine at monthly intervals 2. Remain on their medications for three years 3. Endpoint if exhibited a dipstick proteinuria of more than or equal to 1+ |
| Overall study start date | 01/10/1997 |
| Completion date | 31/10/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Key inclusion criteria | 1. Clinical diagnosis of type two diabetes 2. Age 20 years or older 3. Patient consent |
| Key exclusion criteria | 1. Having diabetes for less than five years 2. HbA1c less than 8.0% 3. Taking other medications except for oral hypoglycemic agents or insulin injections 4. Hypertension 5. Inability to understands the implications of the the protocol |
| Date of first enrolment | 01/10/1997 |
| Date of final enrolment | 31/10/2000 |
Locations
Countries of recruitment
- Japan
Study participating centre
Department of Molecular Oncology
Matsumoto
390-8621
Japan
390-8621
Japan
Sponsor information
Asama General Hospital (Japan)
Hospital/treatment centre
Hospital/treatment centre
1862-1
Iwamurada
Saku
385-8558
Japan
| Phone | +81 267 67 2295 |
|---|---|
| asamaghp@avis.ne.jp |
Funders
Funder type
Hospital/treatment centre
Internally funded by participant centre, Asama General Hospital (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
