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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000395-32-GB

Enrollment

Registered

2006-02-13

Start date

2006-03-29

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee

Interventions

Trade Name: Arcoxia Product Name: Arcoxia Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 =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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to investigate the effect of etoricoxib on the pressure pain threshold in patients with osteoarthritis of the knee.;Secondary Objective: The secondary objective of this study is to investigate the effect of etoricoxib on perception of pain in the brain of patients with osteoarthritis of the knee.;Primary end point(s): The main objective of this study is to assess whether COX-2 selective inhibition by etoricoxib reduces central sensitisation of pain in patients with chronic osteoarthritis of the knee using function fMRI scan.	—

Measure

Time frame

Main Objective: The main objective of this study is to investigate the effect of etoricoxib on the pressure pain threshold in patients with osteoarthritis of the knee.;Secondary Objective: The secondary objective of this study is to investigate the effect of etoricoxib on perception of pain in the brain of patients with osteoarthritis of the knee.;Primary end point(s): The main objective of this study is to assess whether COX-2 selective inhibition by etoricoxib reduces central sensitisation of pain in patients with chronic osteoarthritis of the knee using function fMRI scan.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026