The effect of COX-2 Inhibition on Reducing Central Sensitisation of Pain in Osteoarthritis

Phase 1

• Conditions: Osteoarthritis of the knee

• Registration Number: EUCTR2006-000395-32-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-13
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age > 18 years old • Patient must be right handed • Patients with ACR criteria defined OA of the knee. • All patients must have radiological OA and pain for more than 1 year. • All patients must have given signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• History of hypersensitivity to the active substance or to any of the excipients. • Active peptic ulceration or active gastro-intestinal (GI) bleeding. • Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclo-oxygenase-2) inhibitors. • Pregnancy and lactation. • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >=10). • Estimated renal creatinine clearance <30 ml/min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV). • Patients with hypertension whose blood pressure has not been adequately controlled. • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease. - Previous history of cerebrovascular accident or disease of the central nervous system. - Taking any non-specific NSAID. - Any contraindication to fMRI scan such as: 1. patients suffering from claustrophobia 2. patient with magnetic metal implant in the body 3. patient with cardiac pacemaker

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified