Celebrex In Acute Gouty Arthritis Study - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity [ Time Frame: Baseline and Day 2 ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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).
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 ] [ Designated as safety issue: No ]
Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
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 ] [ Designated as safety issue: No ]
Redness was assessed by the physician as present or absent.
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 ] [ Designated as safety issue: No ]
Warmth was assessed by the physician as present or absent.
Change From Baseline in Patient's Assessment of Pain Intensity [ Time Frame: Baseline, Day 2 to Day 13 ] [ Designated as safety issue: No ]
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).
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) ] [ Designated as safety issue: No ]
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).
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 ] [ Designated as safety issue: No ]
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
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 ] [ Designated as safety issue: No ]
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).
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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).
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 ] [ Designated as safety issue: No ]
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.
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy [ Time Frame: Day 1 to Day 8 ] [ Designated as safety issue: No ]
Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Participants Global Evaluation of Study Medication Score [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
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
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events [ Time Frame: Baseline to Day 14/Early Termination ] [ Designated as safety issue: Yes ]
The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events [ Time Frame: Baseline to Day 14/Early Termination ] [ Designated as safety issue: Yes ]
The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.

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
Active Comparator: 1	Drug: Indomethacin indomethacin 50 mg three times a day (TID) for 8 days.
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.
Experimental: 3	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.
Experimental: 4	Drug: Celecoxib Celecoxib 50 mg two times a day (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 by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Responsible Party:	Director Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00549549 History of Changes
Other Study ID Numbers:	A3191219
Study First Received:	October 24, 2007
Results First Received:	December 17, 2010
Last Updated:	January 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Indomethacin
Celecoxib
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses

Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013