Food and Drug Administration
Center
for Drug Evaluation and Research (CDER)
Arthritis
Advisory Committee
Questions to the Committee
Individuals with acute gout often
experience significant pain. Although standard treatments include NSAIDs, colchicine and glucocorticoids, none of these agents have been
demonstrated to be efficacious in placebo-controlled, randomized double-blind
studies. Therefore, it is important to carefully assess any new therapy for
efficacy.
I. Please discuss
whether gout is considered a unique clinical entity or a model of acute pain?
II. Please comment
on the use of the following clinical measures: pain intensity, pain relief,
time to onset of analgesia, time to re-medication
III. Attacks of gout
may be self limited and resolve spontaneously over 1-2 weeks.
· Please discuss
the duration of a trial for acute gout.
· What is the
value of a demonstration of efficacy within the first 8 hours?
The first day?
· Is there
clinical meaning in an analysis of average of pain over several days? How many
days?
IV. The onset and
duration of an acute attack is unpredictable and the extent of pain during an
acute attack of gout is variable.
· Please discuss
the clinical trial implications of enrollment of patients who have already had
symptoms of an acute attack for a period of time (for example 48 hours).
· Please discuss
the clinical trial implications of enrolling patients who may be untreated or
partially treated.
V. Considering the
extent of pain and duration of attacks at trial entrance, please discuss the
advantages and disadvantages of placebo-controlled studies vs.
active-controlled trials. If
placebo-controlled studies are not recommended, are there data from studies of
existing therapies sufficient to define a margin of non-inferiority?
Food and Drug Administration
Center
for Drug Evaluation and Research (CDER)
Arthritis
Advisory Committee
Questions to the Committee (cont.)
VI. Please discuss the following
clinical trial issues: