Unique ID issued by UMIN | UMIN000019123 |
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Receipt number | R000022106 |
Scientific Title | Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer in safety, efficiency and pharmacokinetics (Phase I/IIa) |
Date of disclosure of the study information | 2015/10/01 |
Last modified on | 2017/01/21 16:46:32 |
Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer in safety, efficiency and pharmacokinetics (Phase I/IIa)
Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer
Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer in safety, efficiency and pharmacokinetics (Phase I/IIa)
Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer
Japan |
Diabetic skin ulcer, Leg ulcer
Geriatrics | Dermatology |
Others
NO
To evaluate the effect of SR-0379 or placebo for 4 weeks treatment on skin ulcer in safety, efficiency and pharmacological aspect
Safety,Efficacy
Exploratory
Phase I,II
Ulcer size at 4 weeks after treatment
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
4
Treatment
Medicine |
SR-0379(0.02%) is sprayed to skin ulcer once per day for 28 days.
SR-0379(0.1%) is sprayed to skin ulcer once per day for 28 days.
SR-0379(0.5%) is sprayed to skin ulcer once per day for 28 days.
Placebo is sprayed to skin ulcer once per day for 28 days.
20 | years-old | <= |
Not applicable |
Male and Female
1. Over 20 years old
2. Diabetic skin ulcer or leg ulcer (arterial or venous ulcer)
3. Less than 6 cm diameter of skin ulcer
1. infection to be cured with antibiotics
2. Deep ulcer with reaching bone
3. Ulcer due to malignant tumor
4. Severe edema around skin ulcer
5. patients with malignant tumor
6. patients with severe heart failure
7. patients with severe liver, kidner and blood dyufunction
8. worse nutrition status(less than 2 g/dL in serum albumin)
9. worse body status due to severe infection
10. poor control of diabetes (more than 9.0% in HbA1c)
11. Pregnant women, men or women in disagree with birth control during clinical trial period
12. Start or change of drug usage for vasodilators from 2 weeks before SR-0379 or placebo treatment
13. Surgical procedure for skin ulcer from 2 weeks before SR-0379 or placebo treatment
14. Attendance to other clinical trial from 12 weeks before SR-0379 or placebo treatment
15. Judge as an inappropriate patient by physicians
12
1st name | |
Middle name | |
Last name | HIromi Rakugi |
Osaka University Hospital
Geriatric Medicine and Hypertension
2-15 Yamadaoka, Suita, Osaka
06-6879-3852
rakugi@geriat.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hironori Nakagami |
Osaka University
Health Development and Medicine
2-2 Yamadaoka, Suita, Osaka
06-6210-8359
nakagami@gts.med.osaka-u.ac.jp
Osaka University
Japan Agency for Medical Research and Development
Other
NO
大阪大学医学部附属病院(大阪府)、千葉大学医学部附属病院(千葉県)、あさの金町クリニック(東京都)、メディカルプラザ篠崎駅西口(東京都)、春日部中央総合病院(埼玉県)
2015 | Year | 10 | Month | 01 | Day |
Published
The reduction rate (%) of the skin ulcer by SR-0379 at the last evaluation (4th week or discontinuation), were 44.73+/-41.26 (mean+/-SD) for 0.02% group (n=3), 68.25+/-28.98 for 0.1% group (n=3), and 71.61+/-49.17 for 0.5% group (n=3), compared with 9.95+/-65.49 for placebo group (n=3). In 0.5% group, one subject showed complete closure of ulcer at 2nd week and the drug administration was finished, thus the data of 100% reduction at 2nd week was included in the evaluation. In the reduction rate of the skin ulcer, dose dependent change was observed and the results suggest that the effect reaches plateau with the highest dose group.
Six adverse events were reported in 4 subjects, of which one was in placebo group, and causal relationships were denied for all 6 events.
Completed
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 19 | Day |
2016 | Year | 10 | Month | 05 | Day |
2016 | Year | 10 | Month | 30 | Day |
2016 | Year | 11 | Month | 30 | Day |
2017 | Year | 03 | Month | 31 | Day |
2015 | Year | 09 | Month | 26 | Day |
2017 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022106
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