Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141102

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Arthritis, Rheumatoid	Drug: Celecoxib Drug: Diclofenac + Omeprazole	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) [ 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.

Secondary Outcome Measures:

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 ]

Enrollment:	4484
Study Start Date:	October 2005
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Celecoxib Participants are assigned to one of two groups in parallel for the duration of the study
Active Comparator: B	Drug: Diclofenac + Omeprazole Participants are assigned to one of two groups in parallel for the duration of the study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141102

Show 195 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9. Epub 2010 Jun 16.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00141102 History of Changes
Other Study ID Numbers:	A3191084
Study First Received:	August 29, 2005
Results First Received:	May 11, 2010
Last Updated:	April 18, 2011
Health Authority:	United Kingdom: Department of Health

Keywords provided by Pfizer:

GI events in high risk GI arthritis patients

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Diclofenac
Celecoxib
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 21, 2012