Official Title: “Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events”

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • Participants are assigned to one of two groups in parallel for the duration of the study
• Drug: Diclofenac + Omeprazole
  • Participants are assigned to one of two groups in parallel for the duration of the study

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• any event that in clinical practice would impact the subject in terms of inpatient/outpatient investigation for GI pathology with blood loss or other serious complication
  • Time Frame: 13-May-2009
    Safety Issue?: Yes
• The incidence of clinically significant upper and/or lower GI events (CSULGIEs)
  • Time Frame: 13-May-2009
    Safety Issue?: Yes

Secondary Measures

• CSULGIEs plus symptomatic ulcers (SUs)
  • Time Frame: 13-May-2009
    Safety Issue?: Yes
• Incidence of: CSULGIEs, SUs moderate to severe abdominal symptoms, withdrawal due to GI AEs, clinically significant decrease Hct and/or Hb
  • Time Frame: 13-May-2009
    Safety Issue?: Yes
• Hepatic AEs in GGT, AST or ALT of 3xULN
  • Time Frame: 13-May-2009
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
• Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

• Active GD ulceration or GD ulceration within 90 days of the screening visit.
• Concomitant use of low dose aspirin
• Previous MI, stroke or significant vascular disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00141102

Study ID Number: A3191084

ClinicalTrials.gov Identifier: NCT00141102

Health Authority: United Kingdom: Department of Health

To obtain contact information for a study center near you, click here.