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