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| Name | Class |
|---|---|
| United States Air Force | FED |
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This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.
Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol | Active Comparator | Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days |
|
| Sugar pill (Placebo) | Placebo Comparator | Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allopurinol | Drug |
| ||
| Placebo (sugar pill) |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of the Acute Gout Attack | The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack | 1-28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Day 28 | Patient rated pain on a Likert pain score of 0-10 | Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported |
| Physician Global Assessment of Gout Activity at Day 28 |
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Inclusion Criteria requires both of:
Plus one of the following:
Exclusion Criteria:
Inability to return for examinations
Glomerular filtration rate (calculated) less than 50 milliliters per minute
Allopurinol use in past 6 months
Ongoing cancer therapy
Concomitant azathioprine or cyclophosphamide
Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:
Pre-gout pain in involved joint of more than 3 on a scale of 1-10
Neurologic deficit around the involved joint
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| Name | Affiliation | Role |
|---|---|---|
| Jay B Higgs, MD | 59th Medical Wing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Ambulatory Surgical Center | Lackland Air Force Base | Texas | 78236 | United States |
35 patients were enrolled which achieved a completer number of 31. This was one short of the original completer target of 32. Power analysis suggested that a much larger number would have been required to achieve statistical power, and that enrolling 1-2 more subjects would not have contributed to the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Allopurinol | Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days allopurinol |
| FG001 | Sugar Pill (Placebo) | Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. Placebo (sugar pill) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allopurinol | Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days allopurinol |
| BG001 | Sugar Pill (Placebo) | Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. Placebo (sugar pill) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resolution of the Acute Gout Attack | The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack | Posted | Mean | Standard Deviation | days | 1-28 Days |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allopurinol | Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days allopurinol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay B Higgs, | San Antonio Military Medical Center | 2109160797 | jay.b.higgs.civ@mail.mil |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
Physician rated gout activity is measured on a Likert scale 0-10.
| Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported |
| Serum Uric Acid Level | Blood test (serum) for uric acid level | day 28 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Disease duration | Mean | Full Range | years |
|
| number of prior attacks | Mean | Full Range | number |
|
| participants with history of nephrolithiasis | Number | participants |
|
| participants with tophi | Number | participants |
|
| Participants with erosions | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Pain Day 28 | Patient rated pain on a Likert pain score of 0-10 | Posted | Mean | 95% Confidence Interval | units on a Likert scale | Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported |
|
|
|
| Secondary | Physician Global Assessment of Gout Activity at Day 28 | Physician rated gout activity is measured on a Likert scale 0-10. | Posted | Mean | 95% Confidence Interval | units on a Likert scale | Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported |
|
|
|
| Secondary | Serum Uric Acid Level | Blood test (serum) for uric acid level | Posted | Mean | Standard Error | mg/dl | day 28 |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
| EG001 | Sugar Pill (Placebo) | Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. Placebo (sugar pill) | 2 | 19 | 0 | 19 |
| elevated liver enzymes | Gastrointestinal disorders | Systematic Assessment |
|
| nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002241 | Carbohydrates |