Celebrex In Acute Gouty Arthritis Study

Arthritis, Gouty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549549
• Other study ID #: A3191219
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty

Intervention

Drug:
• Indomethacin
indomethacin 50 mg three times a day (TID) for 8 days.
• 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 two times a day (BID) for 7 days.
• 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 two times a day (BID) for 7 days.
• Celecoxib
Celecoxib 50 mg two times a day (BID) for 8 days

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Langley	British Columbia
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Windsor	Ontario
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bucaramanga	Santander
Costa Rica	Pfizer Investigational Site	Cartago
Costa Rica	Pfizer Investigational Site	Heredia
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Suwon-si	Kyeongki-do
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexico	D.f.
Mexico	Pfizer Investigational Site	Mexico	DF
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Philippines	Pfizer Investigational Site	Las Piñas City
Philippines	Pfizer Investigational Site	Lipa City	Batangas
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon City
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Petrozavodsk
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Spain	Pfizer Investigational Site	Sevilla
Taiwan	Pfizer Investigational Site	Hualien
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Khon Kaen
Thailand	Pfizer Investigational Site	Phayathai	Bangkok
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Bryan	Texas
United States	Pfizer Investigational Site	Chaska	Minnesota
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Columbus	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Dunwoody	Georgia
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Havertown	Pennsylvania
United States	Pfizer Investigational Site	Lansing	Michigan
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Longmont	Colorado
United States	Pfizer Investigational Site	Lyndhurst	Ohio
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	Mount Sterling	Kentucky
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	Northglenn	Colorado
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Paradise Valley	Arizona
United States	Pfizer Investigational Site	Peoria	Arizona
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	Roseville	California
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Luis Obispo	California
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Statesville	North Carolina
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tyler	Texas
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Willoughby Hills	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Costa Rica,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Russian Federation,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness	Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).	Baseline, Day 5, Day 9, and Day 14/Early Termination
Secondary	Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling	Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)	Baseline, Days 5, 9 and 14/Early Termination
Secondary	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	Redness was assessed by the physician as present or absent.	Baseline, Day 5, Day 9 and Day 14/Early Termination
Secondary	Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14	Warmth was assessed by the physician as present or absent.	Baseline, Day 5, Day 9 and Day 14
Secondary	Change From Baseline in Patient's Assessment of Pain Intensity	The Patient's assessment of pain 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), and Extreme (4).	Baseline, Day 2 to Day 13
Secondary	Change From Baseline in Patient's Assessment of Pain Intensity on Day 1	The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).	Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Secondary	Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours	Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity	Baseline, 8, 12, and 24 hours post first dose
Secondary	Number of Participants With =30% and =50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity	The Patient's assessment of pain 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), and Extreme (4).	Baseline, Day 2
Secondary	Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline	The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).	Baseline
Secondary	Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13	The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.	Baseline to Day 13
Secondary	Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy	Withdrawal due to lack of efficacy was assessed from Days 1 to 8	Day 1 to Day 8
Secondary	Participants Global Evaluation of Study Medication Score	The participant rated the study medication that they received during the study by completing the following question: How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor	Day 9
Secondary	Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events	The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)	Baseline to Day 14/Early Termination
Secondary	Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events	The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.	Baseline to Day 14/Early Termination

External Links

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