Celebrex In Acute Gouty Arthritis Study

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1W 4R4
        • Pfizer Investigational Site
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Pfizer Investigational Site
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3M 3E5
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada, N8X 5A6
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • Pfizer Investigational Site
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Pfizer Investigational Site
      • Barranquilla, Atlantico, Colombia, 0000
        • Pfizer Investigational Site
    • Santander
      • Bucaramanga, Santander, Colombia
        • Pfizer Investigational Site
  • Costa Rica
      • Cartago, Costa Rica
        • Pfizer Investigational Site
      • Heredia, Costa Rica
        • Pfizer Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-718
        • Pfizer Investigational Site
    • Kyeongki-do
      • Suwon-si, Kyeongki-do, Korea, Republic of, 443-721
        • Pfizer Investigational Site
  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 06726
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 06700
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, L27
        • Pfizer Investigational Site
      • Lima, Peru, 11
        • Pfizer Investigational Site
      • Lima, Peru, 34
        • Pfizer Investigational Site
  • Philippines
      • Las Piñas City, Philippines, 1742
        • Pfizer Investigational Site
      • Manila, Philippines, 1000
        • Pfizer Investigational Site
      • Manila, Philippines, 1003
        • Pfizer Investigational Site
      • Manila, Philippines, 1008
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1102
        • Pfizer Investigational Site
    • Batangas
      • Lipa City, Batangas, Philippines, 4217
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • Petrozavodsk, Russian Federation, 185019
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194291
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 193015
        • Pfizer Investigational Site
  • Spain
      • Sevilla, Spain, 41014
        • Pfizer Investigational Site
  • Taiwan
      • Hualien, Taiwan, 970
        • Pfizer Investigational Site
      • Taichung, Taiwan, 404
        • Pfizer Investigational Site
      • Taipei, Taiwan, 106
        • Pfizer Investigational Site
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Pfizer Investigational Site
    • Bangkok
      • Phayathai, Bangkok, Thailand, 10400
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Pfizer Investigational Site
      • Mesa, Arizona, United States, 85202
        • Pfizer Investigational Site
      • Paradise Valley, Arizona, United States, 85253
        • Pfizer Investigational Site
      • Peoria, Arizona, United States, 85381
        • Pfizer Investigational Site
    • California
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103-6204
        • Pfizer Investigational Site
      • San Luis Obispo, California, United States, 93405
        • Pfizer Investigational Site
    • Colorado
      • Longmont, Colorado, United States, 80501
        • Pfizer Investigational Site
      • Northglenn, Colorado, United States, 80234
        • Pfizer Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32607
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Dunwoody, Georgia, United States, 30338
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Mount Sterling, Kentucky, United States, 40353
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71105-5634
        • Pfizer Investigational Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Pfizer Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48910-8595
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Pfizer Investigational Site
      • Columbus, Missouri, United States, 65212
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Pfizer Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • Pfizer Investigational Site
    • Ohio
      • Lyndhurst, Ohio, United States, 44124
        • Pfizer Investigational Site
      • Willoughby Hills, Ohio, United States, 44094
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Havertown, Pennsylvania, United States, 19083
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • New Tazewell, Tennessee, United States, 37825
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77706
        • Pfizer Investigational Site
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78224
        • Pfizer Investigational Site
      • Tyler, Texas, United States, 75701
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2
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 two times a day (BID) for 7 days.
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 two times a day (BID) for 7 days.
Drug: Celecoxib
Celecoxib 50 mg two times a day (BID) for 8 days
Experimental: 3
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 two times a day (BID) for 7 days.
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 two times a day (BID) for 7 days.
Drug: Celecoxib
Celecoxib 50 mg two times a day (BID) for 8 days
Experimental: 4
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 two times a day (BID) for 7 days.
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 two times a day (BID) for 7 days.
Drug: Celecoxib
Celecoxib 50 mg two times a day (BID) for 8 days
Active Comparator: 1
Drug: Indomethacin
indomethacin 50 mg three times a day (TID) for 8 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Time Frame: Baseline and Day 2
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Time Frame: Baseline, Day 5, Day 9, and Day 14/Early Termination
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
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Time Frame: Baseline, Days 5, 9 and 14/Early Termination
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
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
Time Frame: Baseline, 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
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14
Time Frame: Baseline, 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
Change From Baseline in Patient's Assessment of Pain Intensity
Time Frame: Baseline, Day 2 to Day 13
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
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1
Time Frame: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
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)
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours
Time Frame: Baseline, 8, 12, and 24 hours post first dose
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
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Time Frame: Baseline, Day 2
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
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline
Time Frame: 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
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
Time Frame: Baseline to Day 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
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy
Time Frame: Day 1 to Day 8
Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Day 1 to Day 8
Participants Global Evaluation of Study Medication Score
Time Frame: Day 9

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
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events
Time Frame: Baseline to Day 14/Early Termination
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
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events
Time Frame: Baseline to Day 14/Early Termination
The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.
Baseline to Day 14/Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3191219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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