Clinical trial NCT00977444: Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
Official title: Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Keywords: knee
osteoarthritis
Lead sponsor: Nucitec
Sponsor class: INDUSTRY
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2009-09-15
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Queretaro
country: Mexico
facility: Hospital San Jose
Study officials:
affiliation: Hospital San Jose
name: Ricardo Amador, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caamano MDC, Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Rosado JL. A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Feb 16;10:1179544116688899. doi: 10.1177/1179544116688899. eCollection 2017.
citation: Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Caamano Mdel C, Rosado JL. Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial. BMC Musculoskelet Disord. 2015 May 13;16:114. doi: 10.1186/s12891-015-0568-4.