Rheumatoid Arthritis | Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)
Rheumatoid Arthritis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EtoricoxibFilm coated tablet, 90 mg taken once a day for 14 days
Drug:DiclofenacEnteric coated tablet 50 mg given three times a day for 14 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Etoricoxib 90 mgSubject will take Etoricoxib 90 mg for 14 days
DiclofenacFilm coated tablet 50 mgs given three times a day for 14 days
Start Date: April 2010
Completed Date: April 2011
Phase: Phase 4
Primary Outcome: To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.
Secondary Outcome: To explore the effect of Etoricoxib compared to Diclofenac on average daily pain scores, fatigue scores, and quality of life.
Study sponsors, principal investigator, and references
Lead Sponsor: Northumbria Healthcare NHS Foundation Trust