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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Northumbria Healthcare NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067430
First Posted: February 11, 2010
Last Update Posted: February 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northumbria Healthcare NHS Foundation Trust
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Etoricoxib Drug: Diclofenac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Northumbria Healthcare NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To explore the effect of Etoricoxib compared to Diclofenac on average daily pain scores, fatigue scores, and quality of life. [ Time Frame: After 14 days of treatment ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Etoricoxib 90 mg
Subject will take Etoricoxib 90 mg for 14 days
Drug: Etoricoxib
Film coated tablet, 90 mg taken once a day for 14 days
Other Name: Arcoxia
Active Comparator: Diclofenac
Film coated tablet 50 mgs given three times a day for 14 days
Drug: Diclofenac
Enteric coated tablet 50 mg given three times a day for 14 days
Other Name: Voltarol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067430


Contacts
Contact: David J Walker, MD 01912231685 david.walker@nuth.nhs.uk

Locations
United Kingdom
Northumbria Healthcare NHS Foundation Trust Not yet recruiting
North Shields, Tyne and Wear, United Kingdom, NE29 8NH
Principal Investigator: David J Walker, MD         
Sponsors and Collaborators
Northumbria Healthcare NHS Foundation Trust
  More Information

Responsible Party: Dr David Walker, Newcastle Upon Tyne Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01067430     History of Changes
Other Study ID Numbers: IISP 35166
First Submitted: February 10, 2010
First Posted: February 11, 2010
Last Update Posted: February 11, 2010
Last Verified: January 2010

Keywords provided by Northumbria Healthcare NHS Foundation Trust:
Rheumatoid Arthritis
Etoricoxib
Diclofenac
Pain
Stiffness

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors


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