Does Allopurinol Prolong a Treated, Acute Gout Flare?
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|ClinicalTrials.gov Identifier: NCT01988402|
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : January 5, 2015
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: allopurinol Drug: Placebo (sugar pill)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does Allopurinol Prolong a Treated, Acute Gout Flare?|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: Allopurinol
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
Placebo Comparator: Sugar pill (Placebo)
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
|Drug: Placebo (sugar pill)|
- Resolution of the Acute Gout Attack [ Time Frame: 1-28 Days ]The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
- Pain Day 28 [ Time Frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported ]Patient rated pain on a Likert pain score of 0-10
- Physician Global Assessment of Gout Activity at Day 28 [ Time Frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported ]Physician rated gout activity is measured on a Likert scale 0-10.
- Serum Uric Acid Level [ Time Frame: day 28 ]Blood test (serum) for uric acid level
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): NCT01988402
|United States, Texas|
|Wilford Hall Ambulatory Surgical Center|
|Lackland Air Force Base, Texas, United States, 78236|
|Principal Investigator:||Jay B Higgs, MD||Wilford Hall Ambulatory Surgical Center|