Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Knee Osteoarthritis
| ISRCTN | ISRCTN40097939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40097939 |
| Secondary identifying numbers | YXCS-01-LOX |
- Submission date
- 15/11/2012
- Registration date
- 13/12/2012
- Last edited
- 15/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee arthrosis occurs when the protective layer around the knee is damaged due to wear and tear, causing the bones to rub against each other. This causes pain and stiffness. There are a number of different treatment methods, such as taking anti-inflammatory (swelling) medications for pain relief. The medication can come in an ointment or in a tablet to be taken by mouth. However, taking tabulets by mouth can injury the digestive area, liver and kidneys. Using ointment may be a better option. The aim of this study is to compare the results of taking an anti-inflammatory medication called Loxoprofen Sodium Cataplasm as either an ointment or a tablet for the treatment of knee osteoarthritis.
Who can participate?
Patients aged between 18 and 80 years Knee osteoarthritis
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the treatment as an ointment that they apply once a day and a placebo (dummy) tablet three times a day. Those in the second group receive a placebo ointment and the medication as a tablet that is taken three times a day. This is done for four weeks. Participants are followed up to see if their symptoms have improved.
What are the possible benefits and risks of participating?
After you participate this study, you can get better treatment for the knee osteoarthritis. At the same time, there exist some risks. The study drug may induce the drug adverse events. These drug adverse events may occur on you or not.
Where is the study run from?
Peking University and People’s Hospital (China)
When is study starting and how long is it expected to run for?
July 2010 to February 2012
Who is funding the study?
Lead Chemical Co. Ltd (Japan)
Who is the main contact?
Professor Rong Mu
murongster@gmail.com
Contact information
Scientific
People's Hospital
Peking University
11 South Xizhimen Street
Bei Jing
100044
China
Study information
| Study design | Randomized controlled double blind double dummy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact murongster@gmail.com to request a patient 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 knee osteoarthritis |
| Study acronym | SELSOAKO |
| Study objectives | There will be non-inferiority between Loxoprofen Sodium Cataplasm Ointment and its tablet fomuration for the treatment of knee osteoarthritis. |
| Ethics approval(s) | Central Ethic Committee of Peking University People's Hospital, 27 July 2010 ref: 35 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | 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 one time each day, one patch each time (100 mg) + Loxoprofen Sodium tablet 3 times a day, 1 tablet each time (60 mg) Administration duration is 4 weeks, and the prescription is changed for every 2 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Loxoprofen |
| Primary outcome measure | 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 outcome measures | Effective rates against different symptoms |
| Overall study start date | 27/07/2010 |
| Completion date | 10/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/07/2010 |
| Date of final enrolment | 10/02/2012 |
Locations
Countries of recruitment
- China
Study participating centre
100044
China
Sponsor information
Industry
77-3 Himata
Toyama
930-0912
Japan
| Website | http://www.lead-chemical.co.jp |
|---|---|
"ROR" |
https://ror.org/02bexj159 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
15/06/2017: Plain English summary added.
