NCT02010918

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

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..

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 922 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	glucosamine sulfate /chondroitin sulfate - capsules	500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.
DRUG	glucosamine sulfate /chondroitin sulfate - sachet	1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.
DRUG	Cosamin DS®	500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2013-12-13
• Last updated: 2013-12-13

Locations

1 site across 1 country: Brazil