EFO: Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
Study Details
Study Description
Brief Summary
Abstract
Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee.
A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score.
The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: kondrium intraarticular injections once month |
Drug: kondrium
intraarticular injections once month
|
| Experimental: kondrium f
|
Drug: kondrium f
intraarticular injections once month
|
| Active Comparator: corticosteroid intraarticular injections once month |
Drug: methyl prednisolone (corticosteroid)
intraarticular injections once month
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index. [4 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age > 40 years
-
symptomatic evidence of OA in the knee for at least 1 year
-
radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
-
no intra-articular injection of corticosteroids within the last 3 months
Exclusion Criteria:
-
any history of adverse reaction to the study drugs
-
current pregnancy status
-
uncontrolled hypertension
-
active infection
-
undergone surgery/arthroscopy within three months
-
diagnosis of radiographic OA of Kellgren and Lawrence grade I
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital San Jose | Queretaro | Mexico |
Sponsors and Collaborators
- Nucitec
- National Council of Science and Technology, Mexico
Investigators
- Principal Investigator: Ricardo Amador, PhD, Hospital San Jose
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PEE-002-2007