Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)

• Status: Withdrawn
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with early morning pain and stiffness.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northumbria Healthcare NHS Foundation Trust
• Treatments: Diclofenac; Etoricoxib

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

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.