Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis

Tracking Information
First Submitted Date ICMJE	February 8, 2011
First Posted Date ICMJE	February 10, 2011
Last Update Posted Date	February 10, 2011
Study Start Date ICMJE	November 2011
Estimated Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 9, 2011)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: February 9, 2011)	Functional capacity, overall assessment of clinical improvement, assessment of adverse events [ Time Frame: 4 months. ]; 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).
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis
Official Title ICMJE	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.
Brief 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. 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
Condition ICMJE	Osteoarthritis
Intervention ICMJE	Drug: Chondroitin sulfate + Glucosamine sulfate 1 capsule three times daily, preferably in the same period; Drug: Chondroitin sulfate + Glucosamine sulfate 1 sachet per day of the drug dissolved in a beaker with 200 mL water.
Study Arms	Experimental: Chondroitin Sulfate + Glucosamine sulfate Pharmaceutical form capsule. Interventions: Drug: Chondroitin sulfate + Glucosamine sulfate Drug: Chondroitin sulfate + Glucosamine sulfate; Experimental: Chondroitin Sulfate + Glucosamine Sulfate Oral powder. Interventions: Drug: Chondroitin sulfate + Glucosamine sulfate Drug: Chondroitin sulfate + Glucosamine sulfate; Active Comparator: Condroflex® Pharmaceutical form capsule. Interventions: Drug: Chondroitin sulfate + Glucosamine sulfate Drug: Chondroitin sulfate + Glucosamine sulfate; Active Comparator: CONDROFLEX® Oral powder Interventions: Drug: Chondroitin sulfate + Glucosamine sulfate Drug: Chondroitin sulfate + Glucosamine sulfate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: February 9, 2011)	320
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2012
Estimated Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01293305
Other Study ID Numbers ICMJE	CGSGEO1010
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. Sergio Marcolino Rosa, LAL Clinica Pesquisa e Desenvolvimento Ltda.
Study Sponsor ICMJE	Azidus Brasil
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Azidus Brasil
Verification Date	January 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP