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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35249-7201 United States
Contact
1-800-718-1021
ClinicalTrials.gov_Inquiries[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00650455
Pfizer
Completed
Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

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Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
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
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.
Not Provided
Interventional
Phase 4
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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
  • Active Comparator: Arm 2
    Intervention: Drug: naproxen
  • Placebo Comparator: Arm 3
    Intervention: Drug: placebo
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
January 2005
January 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00650455
A3471018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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