Apremilast Therapy for Acute Gouty Arthritis
The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years.
In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin.
This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication.
There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Apremilast Therapy for Acute Gouty Arthritis|
- Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured. [ Time Frame: Day 1, Day 7 and Day 21. ] [ Designated as safety issue: No ]
- Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability [ Time Frame: Day 1, Day 7 and Day 21. ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: Assessed at Day 1, Day 7 and Day 21 study visits ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental treatment for acute gout
apremilast 20 mg taken twice daily by mouth
Active Comparator: indomethacin
Medication currently used for the treatment of acute gout
Drug: indomethacin SR
indomethacin SR 75 mg taken twice daily by mouth