Skip to content

Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Myalgia (SELSOAM)

A randomized, controlled, double-blind, double-dummy clinical trial to evaluate the safety and efficacy of Loxoprofen Sodium Cataplasm ointment (Loxonin;PAP100mg) against myalgia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16227145
Enrollment
160
Registered
2014-12-29
Start date
2010-11-18
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Myalgia Musculoskeletal Diseases Myalgia

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

Sponsors

Lead Chemical Co. Ltd (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: > 18 years, < 80 years, 18 and 80 years included 2. Either sex 3. Any of the following with moderate intensity: resting pain, pressing pain, exercising pain 4. The patients were not treated by drugs for one week before giving the investigational product, and no change in physiotherapy for 2 weeks during the first treatment. 5. 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. Patient's pain caused by external injury and diagnosed as acute 2. Patient's pain diagnosed as neurosis 3. Patients with lesions, poor skin conditions on pasting site, or with cutaneous anaphylaxis 4. Patients who need steroid drugs or other non-steroid analgesics which may interfere the therapeutic method in this clinical trial. 5. Patient with peptic ulcer. 6. Patients with bronchial asthma. 7. 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. 8. Pregnant women, lactating mothers or patients who have the possibility of pregnancy, and want to be pregnant during the trial. 9. Patient allergic to this drug. 10. Patients participating any clinical trials on investigational drug or marketed drug within 3 months before enrollment or during clinical trial 11. Other patients judged to be inappropriate for this clinical trial by the investigator

Design outcomes

Primary

MeasureTime frame
Physical test, including the following four symptoms (rest pain, pressing pain, exercising pain, limited movement); each symptom has four grades: no effect, slightly, median, heavily. Timepoint: measured at baseline, 1 week after treatment, 2 weeks after treatment

Secondary

MeasureTime frame
Effective rates against different symptoms

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026