Phase 3
N=100
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT00955552 ↗Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Feb 2023
Primary outcome: Primary: To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form — 85.4; 88.9 percentage of participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Glucosamine sulphate and chondroitin sulphate association (Drug); Cosamin DS® (Nutramax) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Eurofarma Laboratorios S.A.
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form |
85.4; 88.9 | <0.05 sig |
Summary
The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.
Eligibility Criteria
Inclusion Criteria
- Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study.
- Male or female Subjects, aged upper to 40 years.
- Osteoarthritis of the knee confirmed by radiological examination.
- Visual analogue scale (VAS) > 40 mm.
- Kellgren and Lawrence grade 1 to 3.
- Clinical diagnosis of pain and functional limitation.
Exclusion Criteria
- History of significant trauma or surgery in the affected joint.
- Pregnant women, lactating or not using appropriate contraceptive method.
- History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis.
- Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation 30.
- Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria).
- Systemic administration and/or intra-articular corticosteroids in the last 3 months.
- Have made use of glucosamine and/or chondroitin.
- Lequesne index of > 12.
- Arthroplasty in the affected joint.
- Use of narcotic analgesics.
- Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.
Data sourced from ClinicalTrials.gov (NCT00955552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.