A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma
Subjects will have painful primary or post-operative intermetatarsal neuroma. Each subject
will be randomly allocated to receive either ALGRX 4975 or placebo in a 1:1 ratio. Study
drug or placebo will be injected into the intermetatarsal space containing a painful
neuroma. Subjects will complete weekly assessments for the Average Foot Pain Severity, the 7
Interference Items of the BPI, and the number of analgesic units taken. Some subjects may
be followed by monthly telephone interviews to assess their level of pain over the six-month
period following treatment.
Plasma concentrations will be assessed pre-dose and post dose at 5, 10, 15, 20, 30, and 45
min and at 1, 1.5, 2, 2.5, 3 and 4 hours.
Safety will be assessed at baseline and during the study with adverse events (all visits),
vital signs (Visit 2 pre and post-injection and Visit 3 or at early termination), and
laboratory assessments (hematology, chemistry, urinalysis) and ECG (Screening and Visit 3 or
at early termination). The injection site will be examined and assessed by a 6-point scale
for erythema, edema, and hemorrhage before the injection and at 1, 2 and 4 hours after the
injection. A pain on injection NRS will be assessed immediately post- injection at 15, 30,
and 45 minutes and 1, 2, 3, and 4 hours after study drug administration. A sensory
examination of the foot will be performed before the injection and 4 hours after the
injection and at the completion of the study. If a subject has injection pain, the foot may
be wrapped in ice for up to 20 minutes, analgesic medication may be provided.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Weekly average foot pain severity scores
Eric Diamond, D.P.M.
Crossroads Research, Inc.
United States: Food and Drug Administration
|Crossroads Research, Inc.||Owings Mills, Maryland 21117|
|Jean Brown Research||Salt Lake City, Utah 84124|