Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment (EFO)
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| ClinicalTrials.gov Identifier: NCT00977444 |
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Recruitment Status : Unknown
Verified January 2010 by Nucitec.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2009
Last Update Posted : January 20, 2010
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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 |
|---|---|---|
| Osteoarthritis | Drug: kondrium Drug: kondrium f Drug: methyl prednisolone (corticosteroid) | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment |
| Study Start Date : | November 2007 |
| Estimated Primary Completion Date : | February 2009 |
| Estimated Study Completion Date : | October 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: kondrium
intraarticular injections once month
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Drug: kondrium
intraarticular injections once month |
| Experimental: kondrium f |
Drug: kondrium f
intraarticular injections once month |
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Active Comparator: corticosteroid
intraarticular injections once month
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Drug: methyl prednisolone (corticosteroid)
intraarticular injections once month
Other Name: corticosteroid |
- 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 ]
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977444
| Mexico | |
| Hospital San Jose | |
| Queretaro, Mexico | |
| Principal Investigator: | Ricardo Amador, PhD | Hospital San Jose |
| Responsible Party: | Sandra Garcia, Cindetec |
| ClinicalTrials.gov Identifier: | NCT00977444 |
| Other Study ID Numbers: |
PEE-002-2007 |
| First Posted: | September 15, 2009 Key Record Dates |
| Last Update Posted: | January 20, 2010 |
| Last Verified: | January 2010 |
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knee osteoarthritis |
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |