Apremilast Therapy for Acute Gouty Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00997581|
Recruitment Status : Withdrawn (Colaborator withdrew support.)
First Posted : October 19, 2009
Last Update Posted : April 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Gout||Drug: apremilast Drug: indomethacin SR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Apremilast Therapy for Acute Gouty Arthritis|
|Estimated Study Start Date :||April 2010|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
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
- 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. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997581
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|