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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Nucitec.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by:
Nucitec
ClinicalTrials.gov Identifier:
NCT00977444
First received: September 11, 2009
Last updated: January 19, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Nucitec:

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. [ 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977444

Locations
Mexico
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
  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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 14, 2014