Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)
Information source: Northumbria Healthcare NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Etoricoxib (Drug); Diclofenac (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Northumbria Healthcare NHS Foundation Trust Overall contact: David J Walker, MD, Phone: 01912231685, Email: david.walker@nuth.nhs.uk
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.
Clinical Details
Official title: Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
David J Walker, MD, Phone: 01912231685, Email: david.walker@nuth.nhs.uk
Northumbria Healthcare NHS Foundation Trust, North Shields, Tyne and Wear NE29 8NH, United Kingdom; Not yet recruiting David J Walker, MD, Principal Investigator
Additional Information
Starting date: April 2010
Last updated: February 10, 2010
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