ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Allopurinol Prolong a Treated, Acute Gout Flare?

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: NCT01988402
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : January 5, 2015
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Jay B. Higgs, MD, Wilford Hall Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: allopurinol
Drug: Placebo (sugar pill)
Enrollment 35

Recruitment Details  
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.
Arm/Group Title Allopurinol Sugar Pill (Placebo)
Hide Arm/Group Description

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.

Placebo (sugar pill)

Period Title: Overall Study
Started 16 19
Completed 14 17
Not Completed 2 2
Reason Not Completed
Adverse Event             1             2
Withdrawal by Subject             1             0
Arm/Group Title Allopurinol Sugar Pill (Placebo) Total
Hide Arm/Group Description

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

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 of all reporting groups
Overall Number of Baseline Participants 16 19 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 19 participants 35 participants
61
(40 to 84)
53
(31 to 68)
57
(31 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
Female
2
  12.5%
0
   0.0%
2
   5.7%
Male
14
  87.5%
19
 100.0%
33
  94.3%
Disease duration  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 19 participants 35 participants
5.5
(0 to 20)
4.9
(0 to 17)
5.2
(0 to 20)
number of prior attacks  
Mean (Full Range)
Unit of measure:  Number
Number Analyzed 16 participants 19 participants 35 participants
3.7
(0 to 12)
6.58
(1 to 35)
5.2
(0 to 35)
participants with history of nephrolithiasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
4 1 5
participants with tophi  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
6 6 12
Participants with erosions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
4 4 8
1.Primary Outcome
Title Resolution of the Acute Gout Attack
Hide Description The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Time Frame 1-28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol Sugar Pill (Placebo)
Hide Arm/Group Description:

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

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 Number of Participants Analyzed 14 17
Mean (Standard Deviation)
Unit of Measure: days
15.4  (7.9) 13.4  (7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol, Sugar Pill (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Pain Day 28
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol Sugar Pill (Placebo)
Hide Arm/Group Description:

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

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 Number of Participants Analyzed 16 19
Mean (95% Confidence Interval)
Unit of Measure: units on a Likert scale
1.79
(0 to 4)
2.0
(0 to 4)
3.Secondary Outcome
Title Physician Global Assessment of Gout Activity at Day 28
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol Sugar Pill (Placebo)
Hide Arm/Group Description:

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

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 Number of Participants Analyzed 16 19
Mean (95% Confidence Interval)
Unit of Measure: units on a Likert scale
0
(0 to 0)
0
(0 to 0)
4.Secondary Outcome
Title Serum Uric Acid Level
Hide Description Blood test (serum) for uric acid level
Time Frame day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol Sugar Pill (Placebo)
Hide Arm/Group Description:

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

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 Number of Participants Analyzed 14 17
Mean (Standard Error)
Unit of Measure: mg/dl
6.4  (1.0) 8.2  (1.0)
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Allopurinol Sugar Pill (Placebo)
Hide Arm/Group Description

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

allopurinol

Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.

Placebo (sugar pill)

All-Cause Mortality
Allopurinol Sugar Pill (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Allopurinol Sugar Pill (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      2/19 (10.53%)    
Gastrointestinal disorders     
elevated liver enzymes   0/16 (0.00%)  1/19 (5.26%) 
nausea and vomiting   0/16 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
epistaxis   1/16 (6.25%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allopurinol Sugar Pill (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/19 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jay B Higgs,
Organization: San Antonio Military Medical Center
Phone: 2109160797
Responsible Party: Jay B. Higgs, MD, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT01988402     History of Changes
Other Study ID Numbers: FWH20070235H
First Submitted: November 6, 2013
First Posted: November 20, 2013
Results First Submitted: December 9, 2014
Results First Posted: January 5, 2015
Last Update Posted: February 14, 2018