Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028574
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2002-01-04
Brief Title:
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer
Detailed Description:
OBJECTIVES
Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer
Determine the response of patients to this drug
Determine the toxicity of this drug in these patients
Determine the quality of life of patients treated with this drug
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
Arm I Patients receive oral gabapentin once daily on days 1-28
Arm II Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28
Arm III Patients receive oral gabapentin once daily on days 1-7 twice daily on days 8-14 and three times daily on days 15-28
Arm IV Patients receive oral placebo on one of three schedules corresponding to arms I-III
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
Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer
Determine the response of patients to this drug
Determine the toxicity of this drug in these patients
Determine the quality of life of patients treated with this drug
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
Arm I Patients receive oral gabapentin once daily on days 1-28
Arm II Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28
Arm III Patients receive oral gabapentin once daily on days 1-7 twice daily on days 8-14 and three times daily on days 15-28
Arm IV Patients receive oral placebo on one of three schedules corresponding to arms I-III
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02435 | REGISTRY | NCI Clinical Trials Reporting Program | None |
| NCCTG-N00CB | None | None | None |
| NCI-P01-0199 | None | None | None |
| CDR0000069107 | REGISTRY | None | None |