Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo

NCT00471055 | Completed Phase 3 DMC

• 1 other identifier: Khonkaen-ortho 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether capsaicin gel is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo gel.

Conditions

Osteoarthritis, Knee Joint; Capsicum

Keywords

osteoarthritis; knee; capsaicin gel; capsicum

Outcome Measures

Primary Outcomes (2)

• VAS and WOMAC

  8 months

• VAS and WOMAC

  8-month study

Study Arms (2)

A

EXPERIMENTAL

Capsaicin and placebo controlled,Cross-over design study

Drug: 0.0125% Capsaicin gel "CAPSIKA gel"

B

PLACEBO COMPARATOR

Capsaicin and placebo controlled,Cross-over design study

Drug: Placebo

Interventions

0.0125% Capsaicin gel "CAPSIKA gel" DRUG

A

Placebo DRUG

Placebo

B

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 must meet 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 visit 0.
• 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.
• Subjects with baseline minimum joint space width in the medial compartment of the index knee of \> 1.5 mm at Baseline, measured from radiographs using the MTP view.
• Subjects with baseline minimum joint space width in the lateral compartment of the index knee of \> 2.5 mm at Baseline, measured from radiographs using the MTP view.
• Subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.

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 capsaicin.
• Subjects with skin lesion at the index knee.
• A history of lower extremity surgery within 6 months prior to screening V0.
• Significant prior injury to the index knee within 12 months prior to screening V0.
• 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 treatment within the last 12 months.

Sponsors & Collaborators

• Khon Kaen University: lead
• Bangkok Laboratories and Cosmetics: collaborator

Study Sites (1)

Weerachai Kosuwon

Khon Kaen University, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• weerachai Kosuwon, M.D

  Department of Orthopedics, Faculty of Medicine, Khon kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 9, 2008

Record last verified: 2008-04

Locations

TH (1)