Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment (EFO)
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: kondrium Drug: kondrium f Drug: methyl prednisolone (corticosteroid) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment |
- 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. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 114 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: kondrium
intraarticular injections once month
|
Drug: kondrium
intraarticular injections once month
Other Name: kondrium
|
| Experimental: kondrium f |
Drug: kondrium f
intraarticular injections once month
Other Name: kondrium f
|
|
Active Comparator: corticosteroid
intraarticular injections once month
|
Drug: methyl prednisolone (corticosteroid)
intraarticular injections once month
Other Name: corticosteroid
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| Responsible Party: | Sandra Garcia, Cindetec |
| ClinicalTrials.gov Identifier: | NCT00977444 History of Changes |
| Other Study ID Numbers: | PEE-002-2007 |
| Study First Received: | September 11, 2009 |
| Last Updated: | January 19, 2010 |
| Health Authority: | Mexico: Ethics Committee Mexico: National Council of Science and Technology |
Keywords provided by Nucitec:
|
knee osteoarthritis |
Additional relevant MeSH terms:
|
Joint Diseases Osteoarthritis Musculoskeletal Diseases Arthritis Rheumatic Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013