Phase 3
N=402
Celebrex In Acute Gouty Arthritis Study
Arthritis, Gouty
Bottom Line
View on ClinicalTrials.gov: NCT00549549 ↗Enrolled (actual)
402
Serious AEs
0.3%
Results posted
Feb 2011
Primary outcome: Primary: Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity — 3.03; 2.73; 2.84; 2.83 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indomethacin (Drug); Celecoxib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity |
3.03; 2.73; 2.84; 2.83; -1.14; -1.23 | — |
| SECONDARY Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness |
2.39; 2.15; 2.26; 2.13; -1.44; -1.39 | — |
| SECONDARY Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling |
2.16; 2.08; 2.09; 2.01; -1.22; -1.21 | — |
| 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 |
84; 88; 79; 85; 27; 29 | 0.6402 |
| SECONDARY Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 |
89; 91; 91; 88; 25; 16 | 0.1444 |
| SECONDARY Change From Baseline in Patient's Assessment of Pain Intensity |
3.03; 2.73; 2.84; 2.83; -0.65; -0.85 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 |
3.03; 2.73; 2.84; 2.83; -0.32; -0.28 | — |
| SECONDARY Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours |
3.03; 2.73; 2.84; 2.83; 0.44; 0.42 | — |
| SECONDARY Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity |
58; 69; 75; 82; 43; 57 | 0.0459 sig |
| SECONDARY Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline |
3.03; 2.73; 2.84; 2.83 | — |
| 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 |
-44.13; -53.15; -60.11; 2.83; -51.36; -61.83 | — |
| SECONDARY Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy |
2; 1; 0; 0; 10; 8 | 0.5528 |
| SECONDARY Participants Global Evaluation of Study Medication Score |
3.04; 3.11; 3.27; 3.33 | — |
| SECONDARY Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events |
1; 0; 2; 3 | 0.3173 |
| SECONDARY Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events |
3; 2; 1; 5 | 0.4724 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00549549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.