Gout
Conditions
Keywords
gout, allopurinol
Brief summary
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.
Detailed description
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.
Interventions
DRUGallopurinol
Sponsors
United States Air Force
59th Medical Wing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
requires both of: * Crystal proven gout, and * An acute gout attack within 72 hours of first treatment Plus one of the following: * At least 2 gout attacks in past 12 months * Tophus * Nephrolithiasis * 24hr urine uric acid greater than 1000mg
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: * AST \[Aspartate aminotransferase\] * ALT \[Alanine aminotransferase\] * alkaline phosphatase * Pre-gout pain in involved joint of more than 3 on a scale of 1-10 * Neurologic deficit around the involved joint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of the Acute Gout Attack | 1-28 Days | The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Uric Acid Level | day 28 | Blood test (serum) for uric acid level |
| Pain Day 28 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Allopurinol Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol | 16 |
| 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) | 19 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Sugar Pill (Placebo) | Total | Allopurinol |
|---|---|---|---|
| Age, Continuous | 53 Years | 57 Years | 61 Years |
| Disease duration | 4.9 years | 5.2 years | 5.5 years |
| number of prior attacks | 6.58 number | 5.2 number | 3.7 number |
| Participants with erosions | 4 participants | 8 participants | 4 participants |
| participants with history of nephrolithiasis | 1 participants | 5 participants | 4 participants |
| participants with tophi | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 19 Participants | 33 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 19 |
| serious Total, serious adverse events | 1 / 16 | 2 / 19 |
Outcome results
Primary
Resolution of the Acute Gout Attack
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Time frame: 1-28 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopurinol | Resolution of the Acute Gout Attack | 15.4 days | Standard Deviation 7.9 |
| Sugar Pill (Placebo) | Resolution of the Acute Gout Attack | 13.4 days | Standard Deviation 7.8 |
p-value: 0.5Wilcoxon (Mann-Whitney)
Secondary
Pain Day 28
Patient rated pain on a Likert pain score of 0-10
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Allopurinol | Pain Day 28 | 1.79 units on a Likert scale |
| Sugar Pill (Placebo) | Pain Day 28 | 2.0 units on a Likert scale |
Secondary
Physician Global Assessment of Gout Activity at Day 28
Physician rated gout activity is measured on a Likert scale 0-10.
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Allopurinol | Physician Global Assessment of Gout Activity at Day 28 | 0 units on a Likert scale |
| Sugar Pill (Placebo) | Physician Global Assessment of Gout Activity at Day 28 | 0 units on a Likert scale |
Secondary
Serum Uric Acid Level
Blood test (serum) for uric acid level
Time frame: day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopurinol | Serum Uric Acid Level | 6.4 mg/dl | Standard Error 1 |
| Sugar Pill (Placebo) | Serum Uric Acid Level | 8.2 mg/dl | Standard Error 1 |