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

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Glucosamine sulfate + chondroitin sulfate - MANTECORP
Glucosamine sulfate + chondroitin sulfate - CONDROFLEX
Sponsored by
Mantecorp Industria Quimica e Farmaceutica Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Glucosamine, Chondroitin

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Individuals should not initiate physical activity after the inclusion of the study. If they are already doing regular activities before entering the study, the patient may be included as long as he keeps the activities
  • Individuals with kidney disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Glucosamine-Chondroitin Mantecorp

    Condroflex

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    Paracetamol use
    Another primary outcome measure is the frequency of use of analgesic medication (paracetamol).
    Adverse events
    Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure.

    Secondary Outcome Measures

    Subjective assessment of response to therapy by the investigator and patient
    Subjective criteria for evaluating effectiveness: Edema - will be evaluated according to the opinion of the physician using the Visual Analogue Scale (VAS). Pain - will be assessed according to the opinion of the patient using a visual analog scale (VAS). Stiffness in the joint - will be evaluated via the diary and through the patient's opinion also using the Visual Analogue Scale (VAS)
    Subjective evaluation of tolerability graded as excellent, good, regular or poor
    Subjective evaluation of tolerability to the test and reference drugs will be used as secondary outcome measures. Tolerability will be classified as: Excellent: absence of adverse events; Good: adverse events can be easily tolerated; Regular: adverse events can be tolerated and that do not lead to discontinuation of treatment; Poor: adverse events require treatment discontinuation.

    Full Information

    First Posted
    May 26, 2010
    Last Updated
    July 28, 2010
    Sponsor
    Mantecorp Industria Quimica e Farmaceutica Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01172249
    Brief Title
    Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee
    Official Title
    Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mantecorp Industria Quimica e Farmaceutica Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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. The subjects in this study are immunocompetent men and women, aged between 55 and 80 years, diagnosed with osteoarthritis of the knee. The inclusion will be competitive. Individuals who qualify in the screening period will be randomized to receive during 180 days one of the following regimens below: Therapeutic regimen A: one capsule T.I.D. before meals (drug test - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) Therapeutic regimen B: one capsule T.I.D. before meals (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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    Osteoarthritis, Knee, Glucosamine, Chondroitin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Glucosamine-Chondroitin Mantecorp
    Arm Type
    Experimental
    Arm Description
    1 capsule three times daily before meals (drug test - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp)
    Arm Title
    Condroflex
    Arm Type
    Active Comparator
    Arm Description
    1 capsule three times daily before meals (reference medication - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex ®).
    Intervention Type
    Drug
    Intervention Name(s)
    Glucosamine sulfate + chondroitin sulfate - MANTECORP
    Intervention Description
    1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).
    Intervention Type
    Drug
    Intervention Name(s)
    Glucosamine sulfate + chondroitin sulfate - CONDROFLEX
    Other Intervention Name(s)
    Condroflex ®
    Intervention Description
    1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).
    Primary Outcome Measure Information:
    Title
    WOMAC Index
    Description
    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.
    Time Frame
    180 days
    Title
    Paracetamol use
    Description
    Another primary outcome measure is the frequency of use of analgesic medication (paracetamol).
    Time Frame
    180 days
    Title
    Adverse events
    Description
    Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure.
    Time Frame
    180 days
    Secondary Outcome Measure Information:
    Title
    Subjective assessment of response to therapy by the investigator and patient
    Description
    Subjective criteria for evaluating effectiveness: Edema - will be evaluated according to the opinion of the physician using the Visual Analogue Scale (VAS). Pain - will be assessed according to the opinion of the patient using a visual analog scale (VAS). Stiffness in the joint - will be evaluated via the diary and through the patient's opinion also using the Visual Analogue Scale (VAS)
    Time Frame
    180 days
    Title
    Subjective evaluation of tolerability graded as excellent, good, regular or poor
    Description
    Subjective evaluation of tolerability to the test and reference drugs will be used as secondary outcome measures. Tolerability will be classified as: Excellent: absence of adverse events; Good: adverse events can be easily tolerated; Regular: adverse events can be tolerated and that do not lead to discontinuation of treatment; Poor: adverse events require treatment discontinuation.
    Time Frame
    180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 Individuals should not initiate physical activity after the inclusion of the study. If they are already doing regular activities before entering the study, the patient may be included as long as he keeps the activities Individuals with kidney disease.

    12. IPD Sharing Statement

    Learn more about this trial

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

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