A randomised study of sulindac and epalrestat in diabetic retinopathy
| ISRCTN | ISRCTN54039758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54039758 |
| Protocol serial number | N/A |
| Sponsor | Asama General Hospital (Japan) |
| Funder | Internally funded by participant centre, Asama General Hospital (Japan) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised single-blind uncontrolled parallel-assignment trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sulindac, epalrestat |
| Primary outcome measure(s) |
1. Seven-field stereoscopic retinal photography at baseline, and yearly intervals |
| Key secondary outcome measure(s) |
1. Glycosylated Hemoglobin (GHb) values determine at monthly intervals |
| Completion date | 31/10/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
