Knee Osteoarthritis Clinical Trial
— OA knee PlaiOfficial title:
Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels
Verified date | April 2014 |
Source | Khon Kaen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To determine whether plai cream is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo cream.
Status | Completed |
Enrollment | 120 |
Est. completion date | April 2014 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: Subjects eligible for enrollment in the study met all of the following criteria: 1. Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 2. Ambulatory nom pregnant females and males 40-<80 years of age. 3. Subjects who withdraw pain medication or nutritional supplements for symptom relief for knee OA for a total of at least 15 days before screening. 4. Pain at or below 80 mm on a 100 mm VAS in the index knee. 5. A documented diagnosis of OA of the knee, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening. If OA is presented in both knees the investigator will identify which knee will be X-rayed for study entry, with preference for the knee with more severe pain (<80mm VAS). 6. Has documented radiographic evidence of OA of the knee from the screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading (11) 7. Subjects with baseline minimum joint space width in the medial and lateral compartments of the index knee of > 1.5 mm and > 2.5 mm at Baseline respectively, measured from radiographs using the MTP view. Exclusion Criteria Subjects with any of the following criteria must not be enrolled in the study: 1. Subjects with history of hypersensitivity to Plai. 2. Subjects with skin lesion at the index knee. 3. A history of lower extremity surgery within 6 months prior to screening. 4. Significant prior injury to the index knee within 12 months prior to screening 5. Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee. 6. Treatment with other drugs potentially affecting bone or cartilage metabolism as described below: - chronic systematic corticosteroids - hyaluronan injection into the index knee with in the previous 6 months. - Diacerin or Glucosamine treatment within the last 12 months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Thailand | Khon Kaen | |
Thailand | Faculty of Medicine KhonKaen University | Khonkaen |
Lead Sponsor | Collaborator |
---|---|
Khon Kaen University | and Bangkok drugs Co. |
Thailand,
Guccione AA, Felson DT, Anderson JJ, Anthony JM, Zhang Y, Wilson PW, Kelly-Hayes M, Wolf PA, Kreger BE, Kannel WB. The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. Am J Public Health. 1994 Mar;84(3):351-8. — View Citation
Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. Review. — View Citation
Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet. 1997 May 3;349(9061):1269-76. — View Citation
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Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | This endpoint will be VAS, measured at visit 2-13 (week 1-12) Primary endpoint VAS: The primary endpoint is the change from baseline in VAS. This endpoint will be measured at visit 2-13 (week 1-12) VAS | VAS 0-100 mm. using questionnaire | 3 months | Yes |
Secondary | WOMAC and | The WOMAC score is a tri-dimensional, disease-specific, self-administered health status measure, probing clinically important, subject-relevant symptoms in the area of pain. The subject will answer WOMAC question on pain subscale, using the Linkert scale 0-100 at screening 1st visit to determine eligibility for inclusion in the study. The subject will complete the entire WOMAC questionnaire during visit 2-13 (week 1-12) | 3 months | Yes |
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