Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Knee Osteoarthritis
- Conditions
- Knee osteoarthritisMusculoskeletal DiseasesGonarthrosis [arthrosis of knee]
- Registration Number
- ISRCTN40097939
- Lead Sponsor
- ead Chemical Co. Ltd (Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
1. Age: > 18 years, < 80 years
2. Sex: unrestricted
3. Patients conforming to clinical diagnostic criteria
4. Patients agree to participate this trial and sign informed content form after completely understanding the contents of the clinical trial
1. Patients with digestive ulcers
2. Patients with bronchial asthma
3. 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
4. Pregnant women, lactating women, patients with pregnancy potential, and patients who want to be pregnant during the clinical trial
5. Patients with drug hypersensitivity (aspirin asthma, hypersensitive to loxoprofen sodium or other drugs)
6. Patients with lesions, poor skin conditions on pasting site, or with cutaneous anaphylaxis (dermatitis due to external agent or patients with dermatitis)
7. Patients combining other rheumatic diseases
8. Patients who need steroid drugs or other non-steroid analgesics which may interfere the therapeutic method in this clinical trial
9. Patients participating any clinical trials on investigational drug or marketing drug within 3 months before inclusion or during clinical trial
10. Other patients judged to be inappropriate for this clinical trial by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total effective rates after 4 weeks treatment<br>1. Apparently improved<br>2. Improved<br>3. Slightly improved<br>4. Unchanged<br>5. Slightly aggravated<br>6. Aggravated<br>7. Significantly aggravated
- Secondary Outcome Measures
Name Time Method Effective rates against different symptoms