Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Knee Osteoarthritis

A randomized, controlled, double blind, double dummy clinical trial to evaluate the safety and efficacy of Loxoprofen Sodium Cataplasm Ointment (Loxonin®PAP100mg) against knee osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40097939

Enrollment

160

Registered

2012-12-13

Start date

2010-07-27

Completion date

Unknown

Last updated

2017-07-24

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Study group: Loxoprofen Sodium Cataplasm ointment one time each day, one patch each time (100 mg) + placebo tablet 3 times a day, 1 tablet each time (60 mg) Control group: Placebo Cataplasm ointment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Total effective rates after 4 weeks treatment 1. Apparently improved 2. Improved 3. Slightly improved 4. Unchanged 5. Slightly aggravated 6. Aggravated 7. Significantly aggravated	—

Secondary

Measure	Time frame
Effective rates against different symptoms	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026