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Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment (EFO)

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ClinicalTrials.gov Identifier: NCT00977444
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
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by:
Nucitec

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
Osteoarthritis Drug: kondrium Drug: kondrium f Drug: methyl prednisolone (corticosteroid) 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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: corticosteroid




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Mexico
Hospital San Jose
Queretaro, Mexico
Sponsors and Collaborators
Nucitec
National Council of Science and Technology, Mexico
Investigators
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Principal Investigator: Ricardo Amador, PhD Hospital San Jose

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sandra Garcia, Cindetec
ClinicalTrials.gov Identifier: NCT00977444     History of Changes
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

Keywords provided by Nucitec:
knee
osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Prednisolone
Methylprednisolone
Methylprednisolone Acetate
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