NCT01425853

Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis

Non-Inferiority Clinical Trial On The Efficacy And Safety Of Chondroitin Sulfate And Glucosamine Hydrochloride In Combination Versus Celecoxib In Patients With Knee Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Bioiberica · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).

Detailed description

The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale in knee OA patients with moderate to severe pain.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Chondroitin/Glucosamine (Droglican)	Experimental
DRUG	Celecoxib	Active comparator

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2011-08-30
• Last updated: 2016-02-26
• Results posted: 2016-02-26

Locations

1 site across 1 country: Spain