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Trial record 2 of 188 for:    "Gout"

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
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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    Allopurinol   Sugar Pill (Placebo)
STARTED   16   19 
COMPLETED   14   17 
NOT COMPLETED   2   2 
Adverse Event                1                2 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Total Total of all reporting groups

Baseline Measures
   Allopurinol   Sugar Pill (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   19   35 
Age 
[Units: Years]
Mean (Full Range)
 61 
 (40 to 84) 
 53 
 (31 to 68) 
 57 
 (31 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  12.5%      0   0.0%      2   5.7% 
Male      14  87.5%      19 100.0%      33  94.3% 
Disease duration 
[Units: Years]
Mean (Full Range)
 5.5 
 (0 to 20) 
 4.9 
 (0 to 17) 
 5.2 
 (0 to 20) 
number of prior attacks 
[Units: Number]
Mean (Full Range)
 3.7 
 (0 to 12) 
 6.58 
 (1 to 35) 
 5.2 
 (0 to 35) 
participants with history of nephrolithiasis 
[Units: Participants]
 4   1   5 
participants with tophi 
[Units: Participants]
 6   6   12 
Participants with erosions 
[Units: Participants]
 4   4   8 


  Outcome Measures

1.  Primary:   Resolution of the Acute Gout Attack   [ Time Frame: 1-28 Days ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   Serum Uric Acid Level   [ Time Frame: day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jay.b.higgs.civ@mail.mil



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