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ISRCTN
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ISRCTN40097939
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DOI
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10.1186/ISRCTN40097939
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Safety and Efficacy of Loxoprofen Sodium cataplasm Ointment Against Knee Osteoarthritis
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Scientific title
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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
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Acronym
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SELSOAKO
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Serial number at source
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YXCS-01-LOX
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Study hypothesis
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There will be non-inferiority between Loxoprofen Sodium Cataplasm Ointment and its tablet fomuration for the treatment of knee osteoarthritis.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Central Ethic Committee of Peking University People's Hospital, 27 July 2010 ref: 35
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Study design
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Randomized controlled double blind double dummy study
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Countries of recruitment
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China
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Disease/condition/study domain
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Knee osteoarthritis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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27/07/2010
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Anticipated end date
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10/02/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please contact murongster@gmail.com to request a patient information sheet
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Target number of participants
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160
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Effective rates against different symptoms
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Sources of funding
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Lead Chemical Co. Ltd (Japan)
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Trial website
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Publications
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Contact name
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Prof
Zhan-guo
Li
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Address
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People's Hospital
Peking University
11 South Xizhimen Street
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City/town
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Bei Jing
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Zip/Postcode
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100044
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Country
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China
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Sponsor
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Lead Chemical Co. Ltd (Japan)
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Address
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77-3 Himata
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City/town
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Toyama
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Zip/Postcode
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930-0912
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Country
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Japan
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Sponsor website:
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http://www.lead-chemical.co.jp
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Date applied
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15/11/2012
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Last edited
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13/12/2012
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Date ISRCTN assigned
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13/12/2012
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