Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee

NCT01172249 | Unknown Phase 3

• 1 other identifier: GLI/P/09-1
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority study in 250 individuals (125 individuals per group), with 204 evaluable patients with clinical and radiological diagnosis of osteoarthritis of the knee. Individuals will be randomized to receive during 180 days the test drug(glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) or the reference medication (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®). Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling, stiffness in the joint, consumption of paracetamol and quality of life. The safety assessment will be done by monitoring the incidence of adverse events and their relation to the treatment.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee; Glucosamine; Chondroitin

Outcome Measures

Primary Outcomes (3)

• WOMAC Index

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip.

  180 days

• Paracetamol use

  Another primary outcome measure is the frequency of use of analgesic medication (paracetamol).

  180 days

• Adverse events

  Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure.

  180 days

Secondary Outcomes (2)

• Subjective assessment of response to therapy by the investigator and patient

  180 days

• Subjective evaluation of tolerability graded as excellent, good, regular or poor

  180 days

Study Arms (2)

Glucosamine-Chondroitin Mantecorp

EXPERIMENTAL

1 capsule three times daily before meals (drug test - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp)

Drug: Glucosamine sulfate + chondroitin sulfate - MANTECORP

Condroflex

ACTIVE COMPARATOR

1 capsule three times daily before meals (reference medication - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex ®).

Drug: Glucosamine sulfate + chondroitin sulfate - CONDROFLEX

Interventions

Glucosamine sulfate + chondroitin sulfate - MANTECORP DRUG

1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).

Glucosamine-Chondroitin Mantecorp

Glucosamine sulfate + chondroitin sulfate - CONDROFLEX DRUG

1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).

Also known as: Condroflex ®

Condroflex

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must have 55-80 years of age, of both sexes and all races.
• Individuals diagnosed with osteoarthritis in the knee with grades 2 to 3 according to the scale of Kellgren / Lawrence \[K / L\], in conjunction with the measurement of Joint Space Width (JSW), which considers the joint space width, confirmed by radiological examination (s) of the knee (s) affected (s).
• Grade 1: doubtful narrowing of joint space and possible osteophyte edge Grade 2: defined osteophytes, moderate joint space narrowing Grade 3: moderate multiple osteophytes, definite reduction in joint space, some sclerosis and possible deformity of bone contour Grade 4: large osteophytes, marked joint space narrowing, severe sclerosis and definite deformity of bone contour
• Individuals with the capacity to provide a written informed consent, understand and respond to the questionnaires during the study about their disabilities and also with a willingness to adhere to treatment and attend the scheduled appointments for the study.
• Persons who have observed the period of wash-out of the drugs listed in question Prohibited Medication

You may not qualify if:

• Individuals with a history of hypersensitivity to glucosamine sulfate and chondroitin sulfate or any of the components of the formula
• Individuals who have used any drug in research within the last 30 days
• Individuals with uric acid greater than or equal to 6 mg/dL for women and 7 mg/dL for men or a previous diagnosis of gout and/or on hypouricemic medication
• Individuals who are in physical therapy
• Individuals with bilateral osteoarthritis, in whom the classification of one of the knees does not fit into grade 2 or 3, according to the scale Kellgren / Lawrence (K/L) together with the measure of Joint Space Width (JSW)
• Individuals being treated with glucocorticoid infiltration, or who have injected hyaluronic acid in the joint
• Individuals who underwent arthroplasty in any location to be evaluated
• Individuals with thyroid dysfunctions that are not controlled (these can only be included in the presence of a normal TSH)
• Subjects with decompensated type 2 diabetes mellitus (diagnosed by examination glycated hemoglobin, which should be below 7.5%)
• Individuals with infection (known or suspected) in the joints that require therapy with systemic antibiotics
• Individuals with significant diseases or clinically significant disorder which, according to the investigator, could interfere with the study or require treatment that might interfere with assessment of efficacy and / or safety
• Individuals who have knowledge of being HIV positive or are immunocompromised
• Patients who need to use some of the medications listed in item Forbidden Medication
• Individuals with other neurological or orthopedic alteration that affects the lower limbs
• Individuals with a BMI (Body Mass Index) greater than 27

Sponsors & Collaborators

• Mantecorp Industria Quimica e Farmaceutica Ltd.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: July 29, 2010
• Last Updated: July 29, 2010

Record last verified: 2010-07