Unique ID issued by UMIN | UMIN000009218 |
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Receipt number | R000010828 |
Scientific Title | A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries. |
Date of disclosure of the study information | 2012/10/31 |
Last modified on | 2015/11/04 12:08:27 |
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
Japan |
ankle swelling after lateral ankle sprain injuries.
Orthopedics |
Others
NO
To evaluate the efficacy of EMPYNASE P Tablets in combination with the RICE (rest, ice, compression, and elevation) regimen and applying Flurbiprofen cataplasms to ankle sprain injuries as the standard therapy compared to placebo for 1 week in patients with ankle swelling after lateral ankle sprain injuries by double-blind, parallel group comparative study.
Efficacy
Phase IV
Change in ankle-foot volume from baseline.
Change in ankle circumference from baseline.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
EMPYNASE group
EMPYNASE, The RICE (rest, ice, compression, and elevation) regimen &
Flurbiprofen patch application.
Placebo group
Placebo, The RICE (rest, ice, compression, and elevation) regimen &
Flurbiprofen patch application.
20 | years-old | <= |
Not applicable |
Male and Female
- Patient with ankle sprain after lateral ankle sprain injuries.
- Patient with ankle swelling after lateral ankle sprain injuries.
- Patient who can be measured the ankle-foot volume 24-60 hours after lateral sprain injuries.
- Patient with a surgical operation of ankle sprains
- Patient with history of ankle surgeries or with planned ankle surgeries at the sprain side.
- Patient coexisting with arthritis/ Arthritis Charcot-type / diabetic foot/ varicose vein/ etc.
- Patient coexisting with systemic or localised edema.
- Patient with history of drug-indused hypersensitivity.
- Patient coexisting with coagulopathy.
- Patient coexisting with aspirin induced asthma or history of the same.
200
1st name | |
Middle name | |
Last name | Takeshi Muneta |
Tokyo Medical and Dental University
Department of Joint Surgery and Sports Medicine
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
1st name | |
Middle name | |
Last name | Toshiyuki Yorozuya |
Kaken Pharmaceutical Co., LTD
Clinical Development Department
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
03-5977-5111
Kaken Pharmaceutical Co., LTD
Kaken Pharmaceutical Co., LTD
Profit organization
JAPAN
NO
2012 | Year | 10 | Month | 31 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 04 | Day |
2012 | Year | 11 | Month | 01 | Day |
2014 | Year | 10 | Month | 30 | Day |
2012 | Year | 10 | Month | 30 | Day |
2015 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010828
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