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Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
This study has been completed.
Study NCT00004755   Information provided by Office of Rare Diseases (ORD)
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
September 1995
 
 
 
Complete list of historical versions of study NCT00004755 on ClinicalTrials.gov Archive Site
 
 
 
Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

OBJECTIVE:

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

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Leishmaniasis
  • Drug: allopurinol
  • Drug: glucantime
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
375
 
 

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

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004755
 
199/11679, HSPH-11679
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health
Study Chair: James H. Maguire Harvard School of Public Health
Office of Rare Diseases (ORD)
January 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP