Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
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Purpose
OBJECTIVE:
Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Leishmaniasis |
Drug: allopurinol Drug: glucantime |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil |
| Estimated Enrollment: | 375 |
| Study Start Date: | September 1995 |
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Parasitologically confirmed cutaneous leishmaniasis (lesion of less than 3 months duration)
No mucocutaneous leishmaniasis
No prior leishmaniasis
--Prior/Concurrent Therapy--
No prior treatment for leishmaniasis
--Patient Characteristics--
Hepatic: No clinical or laboratory evidence of hepatic disease
Renal: No clinical or laboratory evidence of renal disease No hyperuricemia or gout
Cardiovascular: No clinical, electrocardiographic, or laboratory evidence of cardiac disease
Other: No allergy or other contraindication to allopurinol or glucantime; No concurrent medication that might interact with study drugs, e.g.: probenecid, warfarin, azathioprine; No skin rash; No malnutrition; No other medical contraindication to protocol therapy; No pregnant or nursing women
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004755 History of Changes |
| Other Study ID Numbers: | 199/11679, HSPH-11679 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
dermatologic disorders environmental/toxic disorders immunologic disorders and infectious disorders leishmaniasis rare disease |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Cutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Allopurinol Meglumine antimoniate Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013