Celebrex In Acute Gouty Arthritis Study - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00549549

Purpose

This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.

Condition	Intervention	Phase
Arthritis, Gouty	Drug: Indomethacin Drug: Celecoxib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Efficacy And Safety Of Celecoxib (Celebrex®) And Indomethacin In The Treatment Of Moderate To Severe Acute Gouty Arthritis

Resource links provided by NLM:

Drug Information available for: Indomethacin Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint of the study will be the Change from Baseline to Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) in the Patient's Assessment of Pain Intensity in the index joint. [ Time Frame: Day 1,2,3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time weighted average change from Baseline in the Patient's Assessment of Pain Intensity over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Incidence of at least a 30% and 50% reduction from Baseline in the Patient's Assessment of Pain Intensity on Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) [ Time Frame: Days 1,2,3 ] [ Designated as safety issue: No ]
Change from Baseline to in the Patient's Assessment of Pain Intensity (24-hour recall of pain experienced during prior day as assessed on the next morning for each day), and average change in this measure over Days 2-5 and Days 2-8 [ Time Frame: Days 3, 4, 5, 6, 7, and 8 ] [ Designated as safety issue: No ]
Incidence of withdrawal due to lack of efficacy on Day 1 and over Days 1-8 [ Time Frame: Days 1-8 ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication score on Day 8 and Day 14 [ Time Frame: Day 8, Day14 ] [ Designated as safety issue: No ]
Physician's Assessment of the Index Joint on : change from Baseline to each post-baseline assessment for "tenderness" and "swelling", and incidence at each post-baseline assessment of "redness [ Time Frame: Day 5, Day 9 and at Day 14, the end of the study visit ] [ Designated as safety issue: No ]
and warmth" [ Time Frame: Day 5, Day 9 and at Day 14, the end of the study visit ] [ Designated as safety issue: No ]
Percent change from Baseline in the Patient's Assessment of Pain Intensity for the prior 24 hours to the average Pain Intensity on Days 2-5 and Days 2-8 [ Time Frame: Days 2-8 ] [ Designated as safety issue: No ]
Change from Baseline in the Patient's Assessment of Pain Intensity at each of 2, 4, 8 and 12 hours post first dose of study medication on Day 1, and both prior to the first dose of study medication on Day 2 (~24 hours after initiating study [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
medication) and prior to the second dose of study medication on Day 2 (~32 hours after initiating study medication) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Time to withdrawal due to lack of efficacy over days 1-8 [ Time Frame: Days 1-8 ] [ Designated as safety issue: No ]

Enrollment:	402
Study Start Date:	February 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Indomethacin indomethacin 50 mg TID for 8 days.
2: Experimental	Drug: Celecoxib An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg BID for 7 days.
3: Experimental	Drug: Celecoxib An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg BID for 7 days.
4: Experimental	Drug: Celecoxib Celecoxib 50 mg BID for 8 days

Eligibility

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

Criteria

Inclusion Criteria:

Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout;
Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1);
A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.

Exclusion Criteria:

Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint;
Acute polyarticular gout involving greater than 4 joints or chronic gout.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549549

Show 81 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

Responsible Party:	Pfizer ( Director Clinical Trial Disclosure Group )
Study ID Numbers:	A3191219
Study First Received:	October 24, 2007
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00549549 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents
Gout Suppressants
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Musculoskeletal Diseases
Tocolytic Agents
Sensory System Agents
Arthritis
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Celecoxib
Metabolic Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Rheumatic Diseases
Gout
Pharmacologic Actions
Arthritis, Gouty
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010