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

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ClinicalTrials.gov Identifier: NCT01067430
Recruitment Status : Unknown
Verified January 2010 by Northumbria Healthcare NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2010
Last Update Posted : February 11, 2010
Sponsor:
Information provided by:
Northumbria Healthcare NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 10, 2010
First Posted Date  ICMJE February 11, 2010
Last Update Posted Date February 11, 2010
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)
Official Title  ICMJE Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etoricoxib
    Film coated tablet, 90 mg taken once a day for 14 days
    Other Name: Arcoxia
  • Drug: Diclofenac
    Enteric coated tablet 50 mg given three times a day for 14 days
    Other Name: Voltarol
Study Arms  ICMJE
  • Active Comparator: Etoricoxib 90 mg
    Subject will take Etoricoxib 90 mg for 14 days
    Intervention: Drug: Etoricoxib
  • Active Comparator: Diclofenac
    Film coated tablet 50 mgs given three times a day for 14 days
    Intervention: Drug: Diclofenac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01067430
Other Study ID Numbers  ICMJE IISP 35166
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr David Walker, Newcastle Upon Tyne Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Northumbria Healthcare NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northumbria Healthcare NHS Foundation Trust
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP