Chap 3 Clinical Studies

Question 1

Study 1 was an open-label, controlled trial involving 52 pediatric patients that were randomized to receive either ELITEK® or ____________.

Answer 1

Allopurinol

Question 2

Studies 2 and 3 tested maintenance of uric acid concentration at 48 hours. Which of the following was included in the definition of maintenance?
A. 48 hours after treatment, patients <13 years achieved a uric acid concentration ≤7.5 mg/dL
B. Control of uric acid level is achieved without help from allopurinol or other agents
C. The specified uric acid concentration had to be maintained until 48 hours after the last dose
D. Uric acid levels must be reduced for 4 weeks following treatment in patients ≥13 years

Answer 2

B. Control of uric acid level is achieved without help from allopurinol or other agents

Question 3

Considering the pooled data from Studies 1-3, what percentage of patients achieved maintenance within 4 hours?
A. 90% 
B. 92% 
C. 93% 
D. 97%

Answer 3

B. 92%

Question 4

Study 4 contained ____ treatment arms in which ELITEK® was administered as a 30-minute _____ once daily and allopurinol was administered orally once daily.

Answer 4

3; infusion

Question 5

In Study 4, what percentage of the patients receiving ELITEK® (Arms A and B) had a documented failure to control uric acid?
A. 0% 
B. 6.5% 
C. 13% 
D. 15%

Answer 5

A. 0%