Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis (CONDOR)

• Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: No ]
  CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.
• Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) [ Time Frame: Month 6/Early Termination (ET) ] [ Designated as safety issue: No ]
  Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor.
• Number of Subjects With SUs [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: No ]
  Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.
• Number of Subjects With CSULGIEs by History of GD Ulceration [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: No ]
  CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.
• Number of Subjects With Moderate to Severe Abdominal Symptoms [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: Yes ]
  Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms".
• Number of Subjects Withdrawn Due to GI Adverse Events (AEs) [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: No ]
  GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.
• Change From Baseline in Hemoglobin at Month 6/ET [ Time Frame: Month 6/ET ] [ Designated as safety issue: Yes ]
• Change From Baseline in Hematocrit at Month 6/ET [ Time Frame: Month 6/ET ] [ Designated as safety issue: Yes ]
• Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: Yes ]
  A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.
• Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN) [ Time Frame: 6 month treatment duration ] [ Designated as safety issue: Yes ]
  GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.
• Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET [ Time Frame: Month 6/ET ] [ Designated as safety issue: Yes ]
• Change From Baseline in Iron Binding Capacity to Month 6/ET [ Time Frame: Month 6/ET ] [ Designated as safety issue: Yes ]
• Change From Baseline in Ferretin to Month 6/ET [ Time Frame: Month 6/ET ] [ Designated as safety issue: Yes ]
• Change From Baseline in C-Reactive Protein to Month 6/ET [ Time Frame: Month 6/ET ] [ Designated as safety issue: Yes ]

• The secondary endpoints of this study are:
• The incidence of CSULGIEs plus symptomatic ulcers (SUs)
• The Patients Global Assessment of Arthritis
• Change in Hb and Hct from Baseline to Visit 6
• The incidence of subjects who have a clinically significant d

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.

• Osteoarthritis
• Arthritis, Rheumatoid

• 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

• Experimental: A
  Intervention: Drug: Celecoxib
• Active Comparator: B
  Intervention: Drug: Diclofenac + Omeprazole

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.