Osteoarthritis, KneePhase 3NCT01172249
Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee
A Phase 3 study testing Glucosamine sulfate + chondroitin sulfate - MANTECORP and Glucosamine sulfate + chondroitin sulfate - CONDROFLEX in people with Osteoarthritis, Knee, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Glucosamine sulfate + chondroitin sulfate - MANTECORP and Glucosamine sulfate + chondroitin sulfate - CONDROFLEX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
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®).
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Glucosamine sulfate + chondroitin sulfate - MANTECORP, Glucosamine sulfate + chondroitin sulfate - CONDROFLEX
- Keywords
- Osteoarthritis, Knee, Glucosamine, Chondroitin
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine sulfate + chondroitin sulfate - MANTECORPDrug
1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).
Glucosamine sulfate + chondroitin sulfate - CONDROFLEXDrug
Also called Condroflex ®
1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine-Chondroitin Mantecorp | Experimental | 1 capsule three times daily before meals (drug test - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) Receives: 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 ®). Receives: Drug: Glucosamine sulfate + chondroitin sulfate - CONDROFLEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Paracetamol use
Another primary outcome measure is the frequency of use of analgesic medication (paracetamol).
Measured: 180 days
Adverse events
Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure.
Measured: 180 days
Secondary outcomes (2)
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)
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172249
- Sponsor's protocol ID
- GLI/P/09-1
- Status last verified
- Jul 2010
- First submitted
- 26 May 2010
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee
- ClinicalTrials.gov ID
- NCT01172249
- Acronym / sponsor ID
- GLI/P/09-1
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Glucosamine, Chondroitin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucosamine-Chondroitin Mantecorp | Experimental | Drug: Glucosamine sulfate + chondroitin sulfate - MANTECORP1 capsule three times daily before meals (drug test - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) |
| Condroflex | Active comparator | Drug: Glucosamine sulfate + chondroitin sulfate - CONDROFLEX1 capsule three times daily before meals (reference medication - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex ®). |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine sulfate + chondroitin sulfate - MANTECORP1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg). | Drug | Glucosamine-Chondroitin Mantecorp |
| Glucosamine sulfate + chondroitin sulfate - CONDROFLEXAlso: Condroflex ®1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg). | Drug | Condroflex |
Primary outcome
WOMAC Index
Time frame: 180 days
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
Time frame: 180 days
Another primary outcome measure is the frequency of use of analgesic medication (paracetamol).
Adverse events
Time frame: 180 days
Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure.
2 secondary outcomes
Subjective assessment of response to therapy by the investigator and patient
Time frame: 180 days
Subjective evaluation of tolerability graded as excellent, good, regular or poor
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glucosamine sulfate + chondroitin sulfate - MANTECORP and Glucosamine sulfate + chondroitin sulfate - CONDROFLEX in people with Osteoarthritis, Knee, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Index (time frame: 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2010.