UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009218 |
|---|---|
| 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 |
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Basic information
Public title
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
Acronym
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
Scientific Title
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
Scientific Title:Acronym
A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with ankle swelling after lateral ankle sprain injuries.
Region
| Japan |
Condition
Condition
ankle swelling after lateral ankle sprain injuries.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in ankle-foot volume from baseline.
Key secondary outcomes
Change in ankle circumference from baseline.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EMPYNASE group
EMPYNASE, The RICE (rest, ice, compression, and elevation) regimen &
Flurbiprofen patch application.
Interventions/Control_2
Placebo group
Placebo, The RICE (rest, ice, compression, and elevation) regimen &
Flurbiprofen patch application.
Interventions/Control_3
Interventions/Control_4
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
- 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.
Key exclusion criteria
- 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.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Muneta |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Yorozuya |
Organization
Kaken Pharmaceutical Co., LTD
Division name
Clinical Development Department
Zip code
Address
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL
03-5977-5111
Homepage URL
Sponsor or person
Institute
Kaken Pharmaceutical Co., LTD
Institute
Department
Personal name
Funding Source
Organization
Kaken Pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 30 | Day |
Last modified on
| 2015 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010828
