NCT01893905

Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis

Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Sulfate in Combination Versus Placebo in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Tedec-Meiji Farma, S.A. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

Detailed description

The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	CS+SG	Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
DRUG	Placebo	Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-07-09
• Last updated: 2017-08-04
• Results posted: 2017-08-04

Locations

1 site across 1 country: Spain