GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00373685

Purpose

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Condition	Intervention	Phase
Osteoarthritis	Drug: Celecoxib Drug: Any commercially available NSAID with the indication for osteoarthritis	Phase IV

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The Efficacy Subscale of the Satisfaction with Current Pain Medication Scale of the PTSS as the secondary measure of patient satisfaction, nsNSAID and celecoxib utilization, Non-study drug utilization,PPI and other gastro-protective drug utilization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of fecal occult blood positivity at study termination. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Incidence of: Moderate to severe abdominal symptoms and withdrawal due to GI AEs, [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Change in Hb and Hct from Baseline to Study Termination visit [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Outcomes Research secondary endpoints [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety secondary endpoints [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Patient satisfaction with celecoxib compared to nsNSAID therapy as measured by a Drug Satisfaction With Pain Medication Question as the primary measure of patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	8000
Study Start Date:	October 2006
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Celecoxib: Experimental dosing as per USPI label	Drug: Celecoxib open-label
NSAIDs: Active Comparator	Drug: Any commercially available NSAID with the indication for osteoarthritis dosing as per USPI label related to the chosen commercially marketed NSAID

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion Criteria:

GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373685

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 804 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:	A3191331
Study First Received:	September 7, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00373685
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

GI events in patients with moderate GI risk treated with NSAIDS

Study placed in the following topic categories:

Celecoxib
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

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

Sensory System Agents
Therapeutic Uses
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