Osteoarthritis MedDRA version: 12.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Trade Name: Arcoxia
Product Name: Etoricoxib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Etoricoxib
CAS Number: 202409-33-4
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Northumbria Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects aged 18 years and over. • Subjects who are NSAID tolerant. • Subjects with a clinical diagnosis of rheumatoid arthritis. • Subjects who are willing to complete QOL questionnaires. • Written 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Co-occurrence of other disabling conditions in addition to rheumatoid arthritis likely to warrant the persistent use of escape analgesia. • Subjects who have received an intra-articular or muscular steroid injection within 3 months of study entry or in whom such treatment is planned within the study period. • Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period. • Severe respiratory impairment. • Clinically significant hepatic or renal dysfunction, subjects whose LFTs and serum creatinine is outside normal recognized limits. • Subjects with convulsive disorders, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure. • Subjects with a known allergy or hypersensitivity to NSAIDs. • Subjects with unstable gastro-intestinal complications or disease. • Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse, or who in the Investigator’s opinion, have previously demonstrated drug-seeking behaviour. • Subjects who are currently participating in another clinical research study involving a new chemical entity or who have participated in a clinical study within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.;Secondary Objective: To explore the effect of Etoricoxib compared to Diclofenac on average daily pain scores, fatigue scores, and quality of life.;Primary end point(s): To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness. | — |
Countries
United Kingdom
Outcome results
None listed