Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004755
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Allopurinol Glucantime or AllopurinolGlucantime for Cutaneous Leishmaniasis in Brazil
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase II Randomized Study of Allopurinol Versus Glucantime Versus AllopurinolGlucantime for Cutaneous Leishmaniasis in Brazil
Status:
COMPLETED
Status Verified Date:
1998-01
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:
OBJECTIVE
Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinolglucantime in patients in Brazil with cutaneous leishmaniasis
Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinolglucantime in patients in Brazil with cutaneous leishmaniasis
Detailed 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 696
The third group receives allopurinol and glucantime
Patients are followed at 3 6 and 9 months then annually for at least 5 years
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 696
The third group receives allopurinol and glucantime
Patients are followed at 3 6 and 9 months then annually for at least 5 years
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 |
|---|---|---|---|
| HSPH-11679 | None | None | None |