- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293305
Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chondroitin Sulfate + Glucosamine sulfate
Pharmaceutical form capsule.
|
1 capsule three times daily, preferably in the same period
1 sachet per day of the drug dissolved in a beaker with 200 mL water.
|
Experimental: Chondroitin Sulfate + Glucosamine Sulfate
Oral powder.
|
1 capsule three times daily, preferably in the same period
1 sachet per day of the drug dissolved in a beaker with 200 mL water.
|
Active Comparator: Condroflex®
Pharmaceutical form capsule.
|
1 capsule three times daily, preferably in the same period
1 sachet per day of the drug dissolved in a beaker with 200 mL water.
|
Active Comparator: CONDROFLEX®
Oral powder
|
1 capsule three times daily, preferably in the same period
1 sachet per day of the drug dissolved in a beaker with 200 mL water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional capacity, overall assessment of clinical improvement, assessment of adverse events
Time Frame: 4 months.
|
Are the secondary objectives:
|
4 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGSGEO1010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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