A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes.
PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms.
All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information.
Patients in all arms may continue therapy with gabapentin for an additional 8 weeks.
Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks.
Patients are followed at 6, 12, and 24 months.
PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.
Required characteristics:
Contraindications:
History of renal insufficiency (defined as a creatinine ≥1.5 x UNL in the last two years).
Any of the following current (≤ 4 weeks) or planned therapies:
History of allergic or other adverse reaction to gabapentin.
Prior use of gabapentin.
Antidepressants (use is allowed if patient has been on a stable dose for ≥1 month and does not plan to modify this treatment during the next 5 weeks).
Washington D.C., District of Columbia 20060, United States
Honolula, Hawaii 96813, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
West Des Moines, Iowa 50266, United States
Wichita, Kansas 67214, United States
Ann Arbor, Michigan 48106-0995, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Westerville, Ohio 43081, United States
Spartanburg, South Carolina 29303, United States