Clinical Trial: Apremilast Therapy for Acute Gouty Arthritis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Apremilast Therapy for Acute Gouty Arthritis
Brief Summary:
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.
Detailed Summary: WITHDRAWN
Sponsor: Dartmouth-Hitchcock Medical Center
Current Primary Outcome: 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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. ]
- Quality of Life [ Time Frame: Assessed at Day 1, Day 7 and Day 21 study visits ]
Original Secondary Outcome: Same as current
Information By: Dartmouth-Hitchcock Medical Center
Dates:
Date Received: October 9, 2009
Date Started: April 2010
Date Completion:
Last Updated: January 20, 2016
Last Verified: January 2016
