Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000793
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Phase IIIII Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IIIII Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To assess the efficacy safety and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy
No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted Both amitriptyline and mexiletine have been useful in the management of painful neuropathies however both are associated with certain toxicities In this comparative study of amitriptyline and mexiletine benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs
No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted Both amitriptyline and mexiletine have been useful in the management of painful neuropathies however both are associated with certain toxicities In this comparative study of amitriptyline and mexiletine benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs
Detailed Description:
No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted Both amitriptyline and mexiletine have been useful in the management of painful neuropathies however both are associated with certain toxicities In this comparative study of amitriptyline and mexiletine benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs
Patients are randomized to receive amitriptyline mexiletine or benztropine mesylate as an active placebo to mimic the mild side effects associated with both amitriptyline and mexiletine Doses are gradually increased over 4 weeks until a minimum effective dose or MTD is reached then patients are treated for at least 4 additional weeks at the final dose before gradually tapering off Neurologic exams are performed at screening and at the end of treatment Intensity of pain is rated twice daily by the patient Patients are followed at Weeks 2 4 and 8 and at 10 days after completely tapering off of drug
PER 31695 AMENDMENT Patients with no pain relief 14 days after initiation of study therapy may have dose doubled or increased to maximum allowable dose whichever is lower Then if no improvement occurs within 14 days after dose increase patients have the option of discontinuing study medication
Patients are randomized to receive amitriptyline mexiletine or benztropine mesylate as an active placebo to mimic the mild side effects associated with both amitriptyline and mexiletine Doses are gradually increased over 4 weeks until a minimum effective dose or MTD is reached then patients are treated for at least 4 additional weeks at the final dose before gradually tapering off Neurologic exams are performed at screening and at the end of treatment Intensity of pain is rated twice daily by the patient Patients are followed at Weeks 2 4 and 8 and at 10 days after completely tapering off of drug
PER 31695 AMENDMENT Patients with no pain relief 14 days after initiation of study therapy may have dose doubled or increased to maximum allowable dose whichever is lower Then if no improvement occurs within 14 days after dose increase patients have the option of discontinuing study medication
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11219 | REGISTRY | DAIDS-ES | None |