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

NCT01836393 | Completed Phase 3 DMC

• 1 other identifier: KKU Ortho Plai
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Keywords

Plai; Efficacy; OA knee; The efficacy study of Plai cream for OA knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• WOMAC and

  3 months

Study Arms (1)

placebo and plai

EXPERIMENTAL

The essential plai cream has anti-inflammatory and antimicrobial effects (Wasuwat1989, Giwanon 2000, Pithayanukul 2007, and Tripathi 2008). Active chemicals of plai cream are composed of sabinene, alpha and gamma tepinenes, terpinen 4-ol and (E)-1-(3,4-dimethoxyphenyl butadiene (DMPBD). The DMPBD has a property of anti-inflammatory activity(Ozaki 1991, Jeenapongsa 2003). Plavina® 40 mg in 100 gm (contains DMPBD of …%). This product was supplied in lacquered aluminum collapsible tube containing 100 gram cream packing.

Drug: Plavina cream

Interventions

Plavina cream DRUG

The essential plai cream has anti-inflammatory and antimicrobial effects (Wasuwat1989, Giwanon 2000, Pithayanukul 2007, and Tripathi 2008). Active chemicals of plai cream are composed of sabinene, alpha and gamma tepinenes, terpinen 4-ol and (E)-1-(3,4-dimethoxyphenyl butadiene (DMPBD). The DMPBD has a property of anti-inflammatory activity(Ozaki 1991, Jeenapongsa 2003). Plavina® 40 mg in 100 gm (contains DMPBD of …%). This product was supplied in lacquered aluminum collapsible tube containing 100 gram cream packing.

placebo and plai

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead
• and Bangkok drugs Co.: collaborator

Study Sites (2)

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

Khon Kaen, Changwat Khon Kaen, 40001, Thailand

Location

Faculty of Medicine KhonKaen University

Khonkaen, KhonKaen, 40001, Thailand

Location

Related Publications (6)

• 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. doi: 10.1136/ard.60.2.91.

  PMID: 11156538 BACKGROUND

• 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. doi: 10.1016/S0140-6736(96)07493-4.

  PMID: 9142060 BACKGROUND

• 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. doi: 10.1136/ard.2003.011742.

  PMID: 14644851 BACKGROUND

• Ozaki Y, Kawahara N, Harada M. Anti-inflammatory effect of Zingiber cassumunar Roxb. and its active principles. Chem Pharm Bull (Tokyo). 1991 Sep;39(9):2353-6. doi: 10.1248/cpb.39.2353.

  PMID: 1804548 BACKGROUND

• Nakatani N. Phenolic antioxidants from herbs and spices. Biofactors. 2000;13(1-4):141-6. doi: 10.1002/biof.5520130123.

  PMID: 11237173 BACKGROUND

• 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. doi: 10.2105/ajph.84.3.351.

  PMID: 8129049 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Weerachai Kosuwon, Doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Orthopedics, Faculty of Medicine

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 19, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

TH (2)