Comparison of the effect of Etoricoxib and Diclofenac on early morning activity in RA.

• Conditions: Osteoarthritis; MedDRA version: 12.1Level: LLTClassification code 10023476Term: Knee osteoarthritis

• Registration Number: EUCTR2009-013786-25-GB
• Lead Sponsor: orthumbria Healthcare NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

•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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.