Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis
Phase 3
Completed
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT02010918
- Lead Sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Brief Summary
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
The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 922
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description glucosamine sulfate /chondroitin sulfate capsule glucosamine sulfate /chondroitin sulfate - capsules 500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily. glucosamine sulfate /chondroitin sulfate - sachet glucosamine sulfate /chondroitin sulfate - sachet 1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily. Cosamin DS® Cosamin DS® 500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS) baseline, week 16
Trial Locations
- Locations (1)
Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas
🇧🇷Campinas, São Paulo, Brazil