Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002996
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Flecainide in Treating Patients With Chronic Neuropathic Pain
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Flecainide for the Treatment of Chronic Neuropathic Pain A Phase II Trial
Status:
COMPLETED
Status Verified Date:
2023-06
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 Flecainide therapy may help patients with neuropathic pain live more comfortably
PURPOSE Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS
PURPOSE Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS
Detailed Description:
OBJECTIVES
Investigate the effectiveness of flecainide in the management of neuropathic pain
OUTLINE Patients are given a brief pain inventory BPI form to assess their pain upon enrollment in the study Following a 7 day stabilization period flecainide is administered One capsule of flecainide is given twice a day on days 8-10 two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21 BPI forms are completed on days 8 15 and 22 to assess neuropathic pain
PROJECTED ACCRUAL A total of 7-20 patients will be accrued for this study
Investigate the effectiveness of flecainide in the management of neuropathic pain
OUTLINE Patients are given a brief pain inventory BPI form to assess their pain upon enrollment in the study Following a 7 day stabilization period flecainide is administered One capsule of flecainide is given twice a day on days 8-10 two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21 BPI forms are completed on days 8 15 and 22 to assess neuropathic pain
PROJECTED ACCRUAL A total of 7-20 patients will be accrued for this study
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 |
|---|---|---|---|
| E1Z95 | None | None | None |