Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Chondroitin/Glucosamine (Droglican); Celecoxib
Intervention description: Experimental; Active comparator
Intervention MeSH terms: Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 606.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 40 years of age

          -  Primary OA of the knee according to the American College of Rheumatology (ACR)
             criteria

          -  OA of radiological stages II or III according to Kellgren and Lawrence

          -  Patients with moderate-severe knee pain

        Exclusion Criteria:

          -  Subjects with active malignancy of any type or history of a malignancy within the last
             five years

          -  Concurrent arthritic disease (antecedents and/or current signs) that could confound or
             interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's
             disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic
             osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis,
             Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed
             connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel
             disease

          -  Pain in other parts of the body greater than the knee pain that could interfere with
             the evaluation of the index joint

          -  Patients with fibromyalgia

          -  Subjects with a history of heart attack or stroke, or who have experienced chest pain
             related to heart disease, or who have had serious diseases of the heart

          -  Subjects with high risk of cardiovascular (CV) events

          -  Subjects with any active acute or chronic infections requiring antimicrobial therapy,
             or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections

          -  Subjects with a history of recurrent Upper Gastrointestinal (UGI) ulceration or active
             inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a
             significant coagulation defect

          -  Subjects who have been diagnosed as having or have been treated for oesophageal,
             gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the
             first dose of study medication

          -  Washout period for OA treatments before beginning the study.