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NCT00000793 · ClinicalTrials.gov registry record · Phase 2
A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT00000793 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 240 participants.
The verdict
NCT00000793, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study 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.
Interventions
- DRUG Amitriptyline hydrochloride
- DRUG Mexiletine hydrochloride
- DRUG Benztropine mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Est. Completion | 1997-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000793
The ClinicalTrials.gov registry entry for NCT00000793 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Amitriptyline hydrochloride is the first listed.
NCT00000793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000793 about?
NCT00000793 is a clinical study titled "A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection". 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 ...
What is the current status of trial NCT00000793?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. Estimated completion is 1997-10.
What interventions are being tested in trial NCT00000793?
The interventions under investigation include: Amitriptyline hydrochloride (DRUG), Mexiletine hydrochloride (DRUG), Benztropine mesylate (DRUG).
Who is sponsoring clinical trial NCT00000793?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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