Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00650455
Previous Study | Return to List | Next Study

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

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.
 
ClinicalTrials.gov Identifier: NCT00650455
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : July 21, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date July 21, 2008
Study Start Date  ICMJE February 2003
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
ACR-20 criteria responder [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
  • Patient's Global Assessment of Disease Activity [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Duration of morning stiffness [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Incidence and time to withdrawal due to insufficient clinical response [ Time Frame: Study endpoint ]
  • Physician's Global Assessment of Disease Activity [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • swollen joint count [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Adverse events [ Time Frame: Baseline, Week 1, Week 6, and Week 12 ]
  • Average rescue medication usage per day [ Time Frame: Study endpoint ]
  • Short Form-36 Acute Health Survey [ Time Frame: Baseline, Week 1, Week 6, and Week 12 ]
  • tender joint count [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • One-Week Severity of Dyspepsia Assessment [ Time Frame: Baseline, Week 1, and Week 12 ]
  • C-reactive protein [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • laboratory tests [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • vital signs [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • physical examinations [ Time Frame: Screening and Week 12 ]
  • ACR-N [ Time Frame: Study endpoint ]
  • Patient Treatment Satisfaction Scale [ Time Frame: Week 1 and Week 6 ]
  • Patient's assessment of arthritis pain (VAS) [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Health Assessment Questionnaire (HAQ) Disability Index [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • swollen joint count [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Adverse events [ Time Frame: Baseline, Week 1, Week 6, and Week 12 ]
  • Average rescue medication usage per day [ Time Frame: Study endpoint ]
  • Short Form-36 Acute Health Survey [ Time Frame: Baseline, Week 1, Week 6, and Week 12 ]
  • tender joint count [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • One-Week Severity of Dyspepsia Assessment [ Time Frame: Baseline, Week 1, and Week 12 ]
  • ACR-20 criteria responder [ Time Frame: Week 1 and Week 6 ]
  • ACR-N [ Time Frame: Study endpoint ]
  • C-reactive protein [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • laboratory tests [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • vital signs [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • physical examinations [ Time Frame: Screening and Week 12 ]
  • Patient's assessment of arthritis pain (VAS) [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Physician's Global Assessment of Disease Activity [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Health Assessment Questionnaire (HAQ) Disability Index [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Patient's Global Assessment of Disease Activity [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Duration of morning stiffness [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Incidence and time to withdrawal due to insufficient clinical response [ Time Frame: Study endpoint ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
Official Title  ICMJE Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population
Brief Summary The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: valdecoxib
    valdecoxib 10 mg tablet once daily for 12 weeks
  • Drug: naproxen
    naproxen 500 mg capsule twice daily for 12 weeks
  • Drug: placebo
    placebo tablet every morning and capsule every evening for 12 weeks
Study Arms  ICMJE
  • Active Comparator: Arm 2
    Intervention: Drug: naproxen
  • Placebo Comparator: Arm 3
    Intervention: Drug: placebo
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
489
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
  • The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab [Humira®] for a minimum of 5 doses on a regular schedule, etanercept [Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)

Exclusion Criteria:

  • A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's opinion, was symptomatic enough to interfere with the evaluation of the effect of valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded from the study
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00650455
Other Study ID Numbers  ICMJE A3471018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2008

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