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Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

Leishmaniasis Clinical Trial

Official title:
Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

Clinical Trial Summary

OBJECTIVE:

Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.

Clinical Trial Description

PROTOCOL OUTLINE:

This is a randomized study. Patients are stratified by participating institution.

One group is treated with daily intramuscular injections of glucantime. Patients with less than a complete response on Day 21 continue treatment until lesions heal completely or for a maximum of 60 days. Patients with progressive disease on Day 40 are removed from study.

The second group is treated with daily oral allopurinol. Patients with a partial response on Day 21 continue treatment until lesions heal completely. Patients with stable or progressive disease on Day 21 or unhealed lesions on Day 56 cross to glucantime therapy. Accrual into this group was closed in 6/96.

The third group receives allopurinol and glucantime.

Patients are followed at 3, 6, and 9 months, then annually for at least 5 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004755
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 2
Start date September 1995
View Details
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