Conditions: Knee Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.

Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX. arm 2: Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.

Interventions: intervention 1: Chondroitin/Glucosamine (Droglican) intervention 2: Celecoxib
Intervention descriptions: intervention 1: Experimental intervention 2: Active comparator

Protocol document: