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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009218

Enrollment

200

Registered

2012-10-31

Start date

2012-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankle swelling after lateral ankle sprain injuries.

Interventions

EMPYNASE group EMPYNASE, The RICE (rest, ice, compression, and elevation) regimen &amp

Flurbiprofen patch application. Placebo group Placebo, The RICE (rest, ice, compression, and elevation) regimen &amp

Flurbiprofen patch application.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in ankle-foot volume from baseline.	—

Secondary

Measure	Time frame
Change in ankle circumference from baseline.	—

Countries

Japan

Contacts

Public ContactToshiyuki Yorozuya

Kaken Pharmaceutical Co., LTD Clinical Development Department

03-5977-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026