A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
Completed
Boehringer Ingelheim
Phase 2
1969-12-31
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.
A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
Completed
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 2
1969-12-31
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.
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