UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019123
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

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Basic information

Public title

Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer in safety, efficiency and pharmacokinetics (Phase I/IIa)

Acronym

Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer

Scientific Title

Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer in safety, efficiency and pharmacokinetics (Phase I/IIa)

Scientific Title:Acronym

Early stage clinical trial to evaluate the effect of SR-0379 on skin ulcer

Region

Japan


Condition

Condition

Diabetic skin ulcer, Leg ulcer

Classification by specialty

Geriatrics Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of SR-0379 or placebo for 4 weeks treatment on skin ulcer in safety, efficiency and pharmacological aspect

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Ulcer size at 4 weeks after treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SR-0379(0.02%) is sprayed to skin ulcer once per day for 28 days.

Interventions/Control_2

SR-0379(0.1%) is sprayed to skin ulcer once per day for 28 days.

Interventions/Control_3

SR-0379(0.5%) is sprayed to skin ulcer once per day for 28 days.

Interventions/Control_4

Placebo is sprayed to skin ulcer once per day for 28 days.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HIromi Rakugi

Organization

Osaka University Hospital

Division name

Geriatric Medicine and Hypertension

Zip code


Address

2-15 Yamadaoka, Suita, Osaka

TEL

06-6879-3852

Email

rakugi@geriat.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironori Nakagami

Organization

Osaka University

Division name

Health Development and Medicine

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6210-8359

Homepage URL


Email

nakagami@gts.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

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.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 19 Day

Last follow-up date

2016 Year 10 Month 05 Day

Date of closure to data entry

2016 Year 10 Month 30 Day

Date trial data considered complete

2016 Year 11 Month 30 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 26 Day

Last modified on

2017 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name