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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00000793 record still lists
NCT00000793 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 3 interventions - of which Amitriptyline hydrochloride is the first listed.
NCT00000793 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000793's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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