Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Myalgia (SELSOAM)
| ISRCTN | ISRCTN16227145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16227145 |
| Protocol serial number | YXCS-02-LOX |
| Sponsor | Lead Chemical Co. Ltd (Japan) |
| Funder | Lead Chemical Co. Ltd (Japan) |
- Submission date
- 03/07/2014
- Registration date
- 29/12/2014
- Last edited
- 07/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Loxonin (loxoprofen sodium) is a kind of non-steroidal anti-inflammatory drug (NSAID). Loxonin tablets are widely used as a painkiller or anti-inflammatory, but like other NSAIDs, they have a number of side effects or adverse reactions (ADR’s). These may include heartburn, headaches, nausea, gastrointestinal problems (such as constipation or diarrhoea) and even intestinal or stomach ulcers. A Loxonin ointment, designed to be applied externally to the skin has therefore been developed in order to reduce the risk of ADR’s when taking the medication. Loxonin is widely used for myalgia (muscle pain). This study aims to compare the effectiveness and safety of the Loxonin ointment with Loxonin tablets for the treatment of myalgia.
Who can participate?
Patients aged 18 to 80 with moderate muscle pain on resting, pressing on the affected muscle or when exercising.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 (the study group) are treated with the Loxonin ointment once a day and a placebo (dummy) tablet three times a day. Those in group 2 (the control group) are treated with a placebo ointment once a day and a loxoprofen sodium tablet three times a day.
What are the possible benefits and risks of participating?
This product has been marketed in Japan for many years and as it’s an external application it’s relatively safe. Participants will receive the treatment for free and given appropriate economic compensation.
Where is the study run from?
1. Peking University People's Hospital (China)
2. Beijing ChaoYang Hospital (China)
3. China-Japan Friendship Hospital (China)
4. The 1st Hospital of Harbin Medical University (China)
5. The 1st Hospital of China Medical University (China)
6. Shanghai Changhai Hospital (China)
7. The 1st Hospital of SuZhou University (China)
8. Union Hospital TongJi Medical College HuaZhong University of Science and Technology, Rheumatism department (China)
9. Union Hospital TongJi Medical College HuaZhong University of Science and Technology, Orthopaedics department (China)
When is the study starting and how long is it expected to run for?
November 2010 to August 2011.
Who is funding the study?
Lead Chemical Co. Ltd (Japan).
Who is the main contact?
Prof Zhanguo Li
Contact information
Scientific
Peking University People's Hospital
No. 11 South Xizhimen Street
Beijing
100044
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled double-blind double-dummy study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomized, controlled, double-blind, double-dummy clinical trial to evaluate the safety and efficacy of Loxoprofen Sodium Cataplasm ointment (Loxonin;PAP100mg) against myalgia |
| Study acronym | SELSOAM |
| Study objectives | There will be non-inferiority between Loxoprofen Sodium Cataplasm Ointment and its tablet formulation for the treatment of myalgia. |
| Ethics approval(s) | Central Ethics Committee of Peking University People's Hospital, 27/07/2010 |
| Health condition(s) or problem(s) studied | Myalgia |
| Intervention | 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 daily, one patch each time (100 mg) + Loxoprofen Sodium tablet 3 times daily, 1 tablet each time (60 mg) Duration of administration is 2 weeks, and the prescription is changed for every 1 week. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Loxoprofen Sodium |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Effective rates against different symptoms |
| Completion date | 24/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/11/2010 |
| Date of final enrolment | 24/08/2011 |
Locations
Countries of recruitment
- China
Study participating centres
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China
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China
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China
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China
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China
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China
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China
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China
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China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/02/2019: Publication reference added.
