Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
RSSEDR
Study hypothesis
The primary purpose is to evaluate the effects of long term treatment with sulindac and epalrestat in diabetic retinopathy.
Ethics approval
Institutional Review Board of Asama General Hospital, date of Approval 01/08/1997 (reference number: AGH 97-01).
Study design
Interventional randomised single-blind uncontrolled parallel-assignment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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 names
Sulindac, epalrestat
Primary outcome measures
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 trial start date
01/10/1997
Overall trial end date
31/10/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Clinical diagnosis of type two diabetes
2. Age 20 years or older
3. Patient consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant 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
Recruitment start date
01/10/1997
Recruitment end date
31/10/2000
Locations
Countries of recruitment
Japan
Trial participating centre
Department of Molecular Oncology
Matsumoto
390-8621
Japan
Sponsor information
Organisation
Asama General Hospital (Japan)
Sponsor details
1862-1
Iwamurada
Saku
385-8558
Japan
+81 267 67 2295
asamaghp@avis.ne.jp
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Internally funded by participant centre, Asama General Hospital (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary