Swelling and pain caused by trauma Signs and Symptoms
Conditions
Interventions
Study group: Loxoprofen Sodium Cataplasm ointment once daily, one patch each time (100 mg) + placebo tablet 3 times daily, 1 tablet each time (60 mg)
Control group: Placebo Cataplasm ointment once d
Sponsors
Lead Chemical Co. Ltd (Japan)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical test, including the following three items: pain (rest pain, rest pain, pressing pain, exercising pain), symptoms of inflammation (swelling, topical burning), limited movement. Timepoint: measured at baseline, 3 days after treatment, 7 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rates of different symptoms | — |
Countries
China
Outcome results
None listed