Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis.

Detailed Description
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The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.

Official Title
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A Phase III, Multicenter, Randomized, Parallel, Open Label and Comparative Study to Evaluate the Efficacy of 500 mg Glucosamine Sulfate (GS) / 400 mg Chondroitin Sulfate (CS)Capsules and 1500 mg GS / 1200 mg CS Sachet Compared With Cosamin DS® Capsule in Treatment of Knee Osteoarthritis..

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: glucosamine sulfate /chondroitin sulfate - capsules
* Drug: glucosamine sulfate /chondroitin sulfate - sachet
* Drug: Cosamin DS®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified: Pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest; Presence of osteophytes at least 1 mm in radiological imaging; Knee osteoarthritis symptoms for at least six months prior to randomization. Exclusion Criteria: Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain; Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described; History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks; Arthroscopy of the affected knee in last 6 months; Serum creatinine ≥ 1.8 mg/dL; Diagnosis of diabetes mellitus; Presence of any serious disease that could compromise the study, at the investigator discretion; History of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate; Inability to understand and report the study questionnaire and the Visual Analogic Scale; Inability to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC); Woman in pregnancy. If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator; Alcohol intake ( > 3 doses/day); Oral or intramuscular corticosteroids four weeks prior to study entry; Intra-articular injections with corticosteroids, into the studied knee, within the past three months; Intra-articular injections in any other joint within the past four weeks; NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit; Intra-articular injections of hyaluronic acid within the past 12 months; Use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other NSAID) two weeks prior to randomization; Implementation of any other medical treatment for osteoarthritis one month prior to study entry; Participation in last one year of clinical protocols, unless it can be direct benefit to patient; Use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively; Initiation of physical therapy two months prior to the study period; Use of tetracycline and oral anticoagulants; Use of vitamin D in doses in doses above the recommended; Patients in alternative therapies; Allergy to sulfonamides; Presence of psychiatric disorders that could compromise the study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucosamine sulfate /chondroitin sulfate capsule<br>500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily. | Drug: glucosamine sulfate /chondroitin sulfate - capsules<br>* 500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.<br>|
| Experimental: glucosamine sulfate /chondroitin sulfate - sachet<br>1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily. | Drug: glucosamine sulfate /chondroitin sulfate - sachet<br>* 1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.<br>|
| Active Comparator: Cosamin DS®<br>500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily. | Drug: Cosamin DS®<br>* 500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 . |  | BASELINE, week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS) |  | baseline, week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis;, Glucosamine;, Chondroitin.