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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 June 2021 |
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Main ID: |
NCT01067430 |
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Date of registration:
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10/02/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)
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Scientific title:
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Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis. |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01067430 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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David J Walker, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northumbria Healthcare NHS Foundation Trust |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Etoricoxib
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Drug: Diclofenac
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Primary Outcome(s)
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To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.
[Time Frame: After 14 days of treatment]
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Secondary ID(s)
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IISP 35166
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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