Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
YXCS-01-LOX
Study information
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
Acronym
SELSOAKO
Study hypothesis
There will be non-inferiority between Loxoprofen Sodium Cataplasm Ointment and its tablet fomuration for the treatment of knee osteoarthritis.
Ethics approval
Central Ethic Committee of Peking University People's Hospital, 27 July 2010 ref: 35
Study design
Randomized controlled double blind double dummy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact murongster@gmail.com to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Loxoprofen
Primary outcome measures
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 trial start date
27/07/2010
Overall trial end date
10/02/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant 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
Recruitment start date
27/07/2010
Recruitment end date
10/02/2012
Locations
Countries of recruitment
China
Trial participating centre
People's Hospital
Bei Jing
100044
China
Sponsor information
Organisation
Lead Chemical Co. Ltd (Japan)
Sponsor details
77-3 Himata
Toyama
930-0912
Japan
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Lead Chemical Co. Ltd (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary