Trial Outcomes & Findings for Does Allopurinol Prolong a Treated, Acute Gout Flare? (NCT NCT01988402)
NCT ID: NCT01988402
Last Updated: 2018-02-14
Results Overview
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
1-28 Days
Results posted on
2018-02-14
Participant Flow
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.
Participant milestones
| Measure |
Allopurinol
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Allopurinol
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
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)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Does Allopurinol Prolong a Treated, Acute Gout Flare?
Baseline characteristics by cohort
| Measure |
Allopurinol
n=16 Participants
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
Sugar Pill (Placebo)
n=19 Participants
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 Years
n=99 Participants
|
53 Years
n=107 Participants
|
57 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Disease duration
|
5.5 years
n=99 Participants
|
4.9 years
n=107 Participants
|
5.2 years
n=206 Participants
|
|
number of prior attacks
|
3.7 number
n=99 Participants
|
6.58 number
n=107 Participants
|
5.2 number
n=206 Participants
|
|
participants with history of nephrolithiasis
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
participants with tophi
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Participants with erosions
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1-28 DaysThe primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Outcome measures
| Measure |
Allopurinol
n=14 Participants
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
Sugar Pill (Placebo)
n=17 Participants
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)
|
|---|---|---|
|
Resolution of the Acute Gout Attack
|
15.4 days
Standard Deviation 7.9
|
13.4 days
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reportedPatient rated pain on a Likert pain score of 0-10
Outcome measures
| Measure |
Allopurinol
n=16 Participants
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
Sugar Pill (Placebo)
n=19 Participants
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)
|
|---|---|---|
|
Pain Day 28
|
1.79 units on a Likert scale
Interval 0.0 to 4.0
|
2.0 units on a Likert scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reportedPhysician rated gout activity is measured on a Likert scale 0-10.
Outcome measures
| Measure |
Allopurinol
n=16 Participants
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
Sugar Pill (Placebo)
n=19 Participants
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)
|
|---|---|---|
|
Physician Global Assessment of Gout Activity at Day 28
|
0 units on a Likert scale
Interval 0.0 to 0.0
|
0 units on a Likert scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: day 28Blood test (serum) for uric acid level
Outcome measures
| Measure |
Allopurinol
n=14 Participants
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
Sugar Pill (Placebo)
n=17 Participants
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)
|
|---|---|---|
|
Serum Uric Acid Level
|
6.4 mg/dl
Standard Error 1.0
|
8.2 mg/dl
Standard Error 1.0
|
Adverse Events
Allopurinol
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill (Placebo)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allopurinol
n=16 participants at risk
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol
|
Sugar Pill (Placebo)
n=19 participants at risk
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
6.2%
1/16 • Number of events 1 • 28 days
|
0.00%
0/19 • 28 days
|
|
Gastrointestinal disorders
elevated liver enzymes
|
0.00%
0/16 • 28 days
|
5.3%
1/19 • 28 days
|
|
Gastrointestinal disorders
nausea and vomiting
|
0.00%
0/16 • 28 days
|
5.3%
1/19 • 28 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place