Condition category
Eye Diseases
Date applied
11/10/2006
Date assigned
12/10/2006
Last edited
16/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Yukiko Hattori

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes