OsteoarthritisPhase 3NCT01293305
Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis
A Phase 3 study testing Chondroitin sulfate + Glucosamine sulfate in people with Osteoarthritis, run by Azidus Brasil.
Trial summary
The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Chondroitin sulfate + Glucosamine sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Constitute the criteria for inclusion in the study:
- Patients who agree with all aspects of the study and sign the Informed Consent
- Patients older than 40 years, regardless of sex
- Patients with clinical and radiological osteoarthritis in at least one knee, grade 1, 2 or 3 (based on clinical and radiological criteria of Kellgren \& Lawrence). In the case of involvement of both knees the knee will be evaluated with greater impairment due to illness
- Patients with symptoms of pain when moving the knee examined in the study on most days of the last month, also in view of randomization of study drugs (V0)
- Symptoms of osteoarthritis, expressed continuously or intermittently over the last 6 months preceding the study
Constitute the criteria for exclusion from the study:
- History of clinically significant trauma to less than 3 months and to keep the clinical signs of trauma
- Patients who have performed surgery (including arthroscopy) in the affected joints less than 3 months and, at the discretion of the investigators, might interfere with study evaluations
- clinical history compatible with arthropathy that may confuse or interfere with pain assessment and effectiveness, including an inflammatory arthropathy (rheumatoid arthritis, lupus erythematosus, espondialoartropatia, psoriatic arthritis, polymyalgia rheumatica) gout, episodes of acute monoarthritis consistent with pseudogout, Paget's disease with involvement of the joint study, a history of septic arthritis, and Wilson disease, hemochromatosis, alkaptonuria, primary osteochondromatosis, history of avascular necrosis or intra-articular fracture of the joint study
- Patients with isolated patellofemoral arthrosis
- Patients who are pregnant or of childbearing potential without contraception
- Patients who are breastfeeding
- Patients with a history of PKU
- Patients with clinical diagnosis of severe renal insufficiency
- Patients with clinical diagnosis of severe liver diseases
- Patients with clinical diagnosis of bleeding disorders
- Patients who are being treated with oral anticoagulants or systemic
- Treatment with corticosteroids:
Use of corticosteroids orally or intramuscularly, fast action, for up to two weeks before V-1 or 14 days before the scheduled visits Use of oral corticosteroids or intramuscular depot for up to 4 weeks before V-1 or 14 days before the scheduled visits the administration of intra-articular corticosteroids in the study joint in the 3 months prior to randomization visit (V0) or during the study the administration of intra-articular corticosteroid into any other joint for up to 4 weeks prior to randomization visit (V0) or during the study
- Patients who have received intra-articular injection of hyaluronic acid or counterparts in the joint study in the past 12 months and during the study period
- Topical use of analgesics and irregular in the joint under study (eg, capsaicin) due to the possibility of causing a worsening of pain
- Use oral and / or systemic analgesics high power (opioids, tramadol) often or last week before the inclusion visit (V0)
- Implementation of any other medical treatment for osteoarthritis in the month prior to entry in the trial or a change of medical treatment already available, such as aerobics or physical therapy
- Clinical diagnosis established uncontrolled diabetes mellitus, with fasting glucose greater than 126 mg / dL
- Patients with a history of daily consumption of alcohol or, at the discretion of the investigator, be considered abusive
- Patients with hypersensitivity or a history of clinical or laboratory adverse event to acetaminophen, chondroitin sulfate and glucosamine sulfate
- Patients with emotional disorders that interfere with the capture of data
- Patients who do not agree with the purposes of the study and did not sign the Informed Consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Evaluation Of Not Less Medical Association Chondroitin Sulfate Plus Glucosamine Sulfate (In Powder Dosage Forms And Oral Capsule), Manufactured By The Geolab Pharmaceutical Industry Ltd, Compared To The Drug Condroflex® (Powder And Oral Capsule), Manufactured In The Laboratory Zodiac, The Treatment Of Osteoarthritis.
The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has long lasting effects even after stopping treatment.
- Conditions
- Osteoarthritis
- Being tested
- Chondroitin sulfate + Glucosamine sulfate
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulfate + Glucosamine sulfateDrug
1 capsule three times daily, preferably in the same period
Chondroitin sulfate + Glucosamine sulfateDrug
1 sachet per day of the drug dissolved in a beaker with 200 mL water.
| Study group | Role | What they receive |
|---|---|---|
| Chondroitin Sulfate + Glucosamine sulfate | Experimental | Pharmaceutical form capsule. Receives: Drug: Chondroitin sulfate + Glucosamine sulfate |
| Chondroitin Sulfate + Glucosamine Sulfate | Experimental | Oral powder. Receives: Drug: Chondroitin sulfate + Glucosamine sulfate |
| Condroflex® | Active comparator | Pharmaceutical form capsule. Receives: Drug: Chondroitin sulfate + Glucosamine sulfate |
| CONDROFLEX® | Active comparator | Oral powder Receives: Drug: Chondroitin sulfate + Glucosamine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Promotion of pain relief in patients with osteoarthritis.
Assessment of noninferiority clinical association Chondroitin + glucosamine in dosage forms and oral powder hard gelatin capsule, produced by Geolab Pharmaceutical Ltd., with the comparator drugs in the same dosage forms produced by the Laboratory Zodiac (Condroflex ®) through the promotion of pain relief in patients with osteoarthritis between grades 1 and 3, according to the classification of Kellgreen \& Lawrence (1957), measured by visual analogue scale (VAS). There will be five visits: V0, V1, V2, V3 and V4.
Measured: 4 months.
Secondary outcomes (1)
Functional capacity, overall assessment of clinical improvement, assessment of adverse events
Are the secondary objectives:
- Functional capacity before and after treatment, using the Lequesne questionnaire, comparing the groups (T and Co).
- Overall evaluation of clinical improvement made by the principal investigator.
- Incidence of use of painkillers and anti-inflammatory drugs orally for the treatment through the patient's report, comparing the groups (T and Co).
- Evaluation of the incidence, type and intensity of adverse events during the study, comparing the groups (T and Co).
Measured: 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293305
- Sponsor's protocol ID
- CGSGEO1010
- Status last verified
- Jan 2011
- First submitted
- 8 Feb 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation Of Not Less Medical Association Chondroitin Sulfate Plus Glucosamine Sulfate (In Powder Dosage Forms And Oral Capsule), Manufactured By The Geolab Pharmaceutical Industry Ltd, Compared To The Drug Condroflex® (Powder And Oral Capsule), Manufactured In The Laboratory Zodiac, The Treatment Of Osteoarthritis.
- ClinicalTrials.gov ID
- NCT01293305
- Acronym / sponsor ID
- CGSGEO1010
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Feb 2011 (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.
The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has long lasting effects even after stopping treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chondroitin Sulfate + Glucosamine sulfate | Experimental | Drug: Chondroitin sulfate + Glucosamine sulfatePharmaceutical form capsule. |
| Chondroitin Sulfate + Glucosamine Sulfate | Experimental | Drug: Chondroitin sulfate + Glucosamine sulfateOral powder. |
| Condroflex® | Active comparator | Drug: Chondroitin sulfate + Glucosamine sulfatePharmaceutical form capsule. |
| CONDROFLEX® | Active comparator | Drug: Chondroitin sulfate + Glucosamine sulfateOral powder |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Chondroitin sulfate + Glucosamine sulfate1 capsule three times daily, preferably in the same period | Drug | CONDROFLEX®, Chondroitin Sulfate + Glucosamine Sulfate, Chondroitin Sulfate + Glucosamine sulfate, Condroflex® |
| Chondroitin sulfate + Glucosamine sulfate1 sachet per day of the drug dissolved in a beaker with 200 mL water. | Drug | CONDROFLEX®, Chondroitin Sulfate + Glucosamine Sulfate, Chondroitin Sulfate + Glucosamine sulfate, Condroflex® |
Primary outcome
Promotion of pain relief in patients with osteoarthritis.
Time frame: 4 months.
Assessment of noninferiority clinical association Chondroitin + glucosamine in dosage forms and oral powder hard gelatin capsule, produced by Geolab Pharmaceutical Ltd., with the comparator drugs in the same dosage forms produced by the Laboratory Zodiac (Condroflex ®) through the promotion of pain relief in patients with osteoarthritis between grades 1 and 3, according to the classification of Kellgreen \& Lawrence (1957), measured by visual analogue scale (VAS). There will be five visits: V0, V1, V2, V3 and V4.
1 secondary outcome
Functional capacity, overall assessment of clinical improvement, assessment of adverse events
Time frame: 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chondroitin sulfate + Glucosamine sulfate in people with Osteoarthritis, run by Azidus Brasil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Feb 2011. 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?
Contact Rosa Marcolino Sergio, Doctor (+551938293822, sergiomarcolino@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Promotion of pain relief in patients with osteoarthritis. (time frame: 4 months.). 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 10 Feb 2011.