Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Swelling and Pain caused By Trauma (SELSOASPBT)

Completed

• Conditions: Swelling and pain caused by trauma; Signs and Symptoms

• Registration Number: ISRCTN10182003
• Lead Sponsor: ead Chemical Co. Ltd (Japan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-29
• Last Update Posted: 6 July 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Age: > 18 years, < 80 years, 18 and 80 years included
2. Either sex
3. Patients diagnosed with traumatic sprain, wound etc. within 5 days of injury
4. Patients with at least one of the following: resting pain, pressing pain, exercising pain and inflammation symptoms (swelling and local burning) considered as more than mild.
5. Patients not treated with drugs for this for 5 days before this trial.
6. Patients agree to participate in the trial and sign informed content form after completely understanding the contents of the clinical trial.

Exclusion Criteria

1. Patients injured over 6 days.
2. Patients with bacterial infections.
3. Patients with fractures, plaster casts or need surgery.
4. Patients with neck sprain (head tremor).
5. Patient with small pasting site (like fingers) could not use the patch.
6. Patients with lesions, poor skin conditions on pasting site, or with cutaneous anaphylaxis.
7. Patients who need steroid drugs or other non-steroid analgesics which may interfere the therapeutic method in this clinical trial.
8. Patient with peptic ulcer.
9. Patients with bronchial asthma.
10. Patients with serious cardiac diseases, hepatic diseases (ALT, AST are equal or bigger than 2.5 times of upper limit), renal diseases (creatinine is equal or bigger than 1.5 times of upper limit), hematologic disease, diabetes, mental diseases, and other serious complications.
11. Pregnant women, lactating mothers or patient have the possibility of pregnancy, and want to be pregnant during the trial.
12. Patient allergic to this drug.
13. Patients participating any clinical trials on investigational drug or marketed drug within 3 months before enrollment or during clinical trial.
14. Other patients judged to be inappropriate for this clinical trial by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified