NCT00838487

Evaluate Safety & Efficacy of Condroflex in Subjects With OA

Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Zodiac Produtos Farmaceuticos S.A. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.

Detailed description

To have osteoarthritis degree 2 or 3 / To be capable to consent

Conditions

• Treatment
• Osteoarthritis
• Elderly

Interventions

Type	Name	Description
OTHER	condroflex and exercise	1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
OTHER	sugar pill and exercise	1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-07-01
• Completion: 2010-03-01
• First posted: 2009-02-06
• Last updated: 2009-10-12

Locations

1 site across 1 country: Brazil