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Status:

COMPLETED

Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels

Lead Sponsor:

Khon Kaen University

Collaborating Sponsors:

and Bangkok drugs Co.

Conditions:

Knee Osteoarthritis

Eligibility:

All Genders

40-80 years

Phase:

PHASE3

Brief Summary

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.

Detailed Description

Osteoarthritis is the most common of the arthritides, affecting at least 20 million Americans, a number that is expected to double over the next two decades. currently available medical therapies prim...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Subjects eligible for enrollment in the study met all of the following criteria:
  • Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Ambulatory nom pregnant females and males 40-\<80 years of age.
  • Subjects who withdraw pain medication or nutritional supplements for symptom relief for knee OA for a total of at least 15 days before screening.
  • Pain at or below 80 mm on a 100 mm VAS in the index knee.
  • 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).
  • 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)
  • 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:
  • Subjects with history of hypersensitivity to Plai.
  • Subjects with skin lesion at the index knee.
  • A history of lower extremity surgery within 6 months prior to screening.
  • Significant prior injury to the index knee within 12 months prior to screening
  • Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2014

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT01836393

    Start Date

    January 1 2013

    End Date

    April 1 2014

    Last Update

    April 8 2014

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Thailand

    Khon Kaen, Changwat Khon Kaen, Thailand, 40001

    2

    Faculty of Medicine KhonKaen University

    Khonkaen, KhonKaen, Thailand, 40001