Celebrex In Acute Gouty Arthritis Study

NCT00549549 | Completed Phase 3 Results DMC

• 1 other identifier: A3191219
• Study Type: interventional
• Target: 402
• Locations: 11 countries
• Sites: 79

Brief Summary

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.

Conditions

Arthritis, Gouty

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity

  The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).

  Baseline and Day 2

Secondary Outcomes (14)

• Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness

  Baseline, Day 5, Day 9, and Day 14/Early Termination

• Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling

  Baseline, Days 5, 9 and 14/Early Termination

• Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination

  Baseline, Day 5, Day 9 and Day 14/Early Termination

• Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14

  Baseline, Day 5, Day 9 and Day 14

• Change From Baseline in Patient's Assessment of Pain Intensity

  Baseline, Day 2 to Day 13

Study Arms (4)

1

ACTIVE COMPARATOR

Drug: Indomethacin

2

EXPERIMENTAL

Drug: Celecoxib

3

EXPERIMENTAL

Drug: Celecoxib

4

EXPERIMENTAL

Drug: Celecoxib

Interventions

Indomethacin DRUG

indomethacin 50 mg three times a day (TID) for 8 days.

1

Celecoxib DRUG

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 two times a day (BID) for 7 days.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (81)

Pfizer Investigational Site

Glendale, Arizona, 85304, United States

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Mesa, Arizona, 85202, United States

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Paradise Valley, Arizona, 85253, United States

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Peoria, Arizona, 85381, United States

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Roseville, California, 95661, United States

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San Diego, California, 92103-6204, United States

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San Luis Obispo, California, 93405, United States

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Longmont, Colorado, 80501, United States

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Northglenn, Colorado, 80234, United States

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DeLand, Florida, 32720, United States

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Gainesville, Florida, 32607, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30342, United States

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Dunwoody, Georgia, 30338, United States

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Rockford, Illinois, 61107, United States

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Lexington, Kentucky, 40504, United States

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Mount Sterling, Kentucky, 40353, United States

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Shreveport, Louisiana, 71105-5634, United States

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Shreveport, Louisiana, 71106, United States

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Wheaton, Maryland, 20902, United States

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Lansing, Michigan, 48910-8595, United States

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Chaska, Minnesota, 55318, United States

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Columbia, Missouri, 65203, United States

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Columbus, Missouri, 65212, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Mineola, New York, 11501, United States

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Statesville, North Carolina, 28625, United States

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Lyndhurst, Ohio, 44124, United States

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Willoughby Hills, Ohio, 44094, United States

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Duncansville, Pennsylvania, 16635, United States

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Havertown, Pennsylvania, 19083, United States

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Nashville, Tennessee, 37203, United States

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New Tazewell, Tennessee, 37825, United States

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Beaumont, Texas, 77701, United States

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Beaumont, Texas, 77706, United States

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Bryan, Texas, 77802, United States

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Dallas, Texas, 75235, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78224, United States

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Tyler, Texas, 75701, United States

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Richmond, Virginia, 23294, United States

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Milwaukee, Wisconsin, 53295, United States

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Langley, British Columbia, V3A 4H9, Canada

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Winnipeg, Manitoba, R2V 4W3, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M3M 3E5, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Québec, Quebec, G1W 4R4, Canada

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Saskatoon, Saskatchewan, S7K 7H9, Canada

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Barranquilla, Atlántico, 0000, Colombia

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Barranquilla, Atlántico, 0, Colombia

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Bucaramanga, Santander Department, Colombia

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Cartago, Costa Rica

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Heredia, Costa Rica

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México, D.F., 06726, Mexico

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Guadalajara, Jalisco, 44100, Mexico

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Mexico City, Mexico City, 06700, Mexico

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Lima, 11, Peru

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Lima, 34, Peru

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Lima, L27, Peru

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Lipa City, Batangas, 4217, Philippines

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Las Piñas, 1742, Philippines

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Manila, 1000, Philippines

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Manila, 1003, Philippines

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Manila, 1008, Philippines

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Quezon City, 1102, Philippines

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Moscow, 115522, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 193015, Russia

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Saint Petersburg, 194291, Russia

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Suwon, Kyeongki-do, 443-721, South Korea

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Daegu, 705-718, South Korea

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Seville, 41014, Spain

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Hualien City, 970, Taiwan

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Taichung, 404, Taiwan

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Taipei, 106, Taiwan

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Phayathai, Bangkok, 10400, Thailand

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Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.

  PMID: 21849262 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Gouty

Interventions

Indomethacin; Celecoxib

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Patients Global Evaluation of study medication data was collected at Day 9 only.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 21, 2021
• Results First Posted: February 24, 2011

Record last verified: 2021-02

Locations

CA (9); RU (4); CO (3); KR (2); TW (3); PE (3); ME (3); ES (1); US (43); TH (2); PH (6)