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

Sponsored by:	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 IV

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome 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: 6 months ] [ Designated as safety issue: Yes ]
The incidence of clinically significant upper and/or lower GI events (CSULGIEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CSULGIEs plus symptomatic ulcers (SUs) [ Time Frame: 6 months ] [ Designated as 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: 6 months ] [ Designated as safety issue: Yes ]
Hepatic AEs in GGT, AST or ALT of 3xULN [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4400
Study Start Date:	October 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 202 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191084
Study First Received:	August 29, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00141102
Health Authority:	United Kingdom: Department of Health

Keywords provided by Pfizer:

GI events in high risk GI arthritis patients

Study placed in the following topic categories:

Celecoxib
Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Omeprazole
Diclofenac
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009