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Sponsored by: |
Combined Military Hospital, Pakistan |
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Information provided by: | Combined Military Hospital, Pakistan |
ClinicalTrials.gov Identifier: | NCT00480883 |
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.
Condition | Intervention |
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Leishmaniasis, Cutaneous |
Drug: meglumine antimoniate, allopurinol Drug: meglumine antimoniate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 Mg/Kg/Day Versus Meglumine Antimoniate 10 Mg/Kg/Day And Tablet Allopurinol 20 Mg/Kg/Day |
Estimated Enrollment: | 400 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
injection meglumine antimoniate 20 mg/kg/day/intramuscular for 21 days.
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Drug: meglumine antimoniate
injectable 20 mg/kg/day/intramuscular for 21 days.
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2: Experimental
injection meglumine antimoniate 10 mg/kg/day/intramuscular plus tablet allopurinol 1200 mg/day/6hourly divided doses.
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Drug: meglumine antimoniate, allopurinol
first drug in injectable, second is in tablet form.
Drug: meglumine antimoniate, allopurinol
injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AMER EJAZ, FCPS | 00 92 300 928 7063 | amer_ejaz@yahoo.com |
Pakistan, PUNJAB | |
Combined Military Hospital | Recruiting |
KHARIAN CANTONMENT, PUNJAB, Pakistan, 74400 | |
Contact: AMER EJAZ 00 92 300 928 7063 amer_ejaz@yahoo.com |
Principal Investigator: | AMER EJAZ, FCPS | Combined Military Hospital, Pakistan |
Responsible Party: | COMBINED MILITARY HOSPITAL, KHARIAN, PAKISTAN ( DR AMER EJAZ ) |
Study ID Numbers: | 001 |
Study First Received: | May 29, 2007 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00480883 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cutaneous leishmaniasis of the old world |
Antimetabolites Leishmaniasis Protozoan Infections Allopurinol Skin Diseases, Infectious Antioxidants |
Skin Diseases Meglumine antimoniate Parasitic Diseases Leishmaniasis, Cutaneous Antirheumatic Agents |
Antimetabolites Anti-Infective Agents Allopurinol Antiprotozoal Agents Antioxidants Molecular Mechanisms of Pharmacological Action Skin Diseases, Parasitic Physiological Effects of Drugs Mastigophora Infections Leishmaniasis, Cutaneous Gout Suppressants Antiparasitic Agents Therapeutic Uses |
Free Radical Scavengers Parasitic Diseases Leishmaniasis Protozoan Infections Skin Diseases Meglumine antimoniate Enzyme Inhibitors Protective Agents Pharmacologic Actions Skin Diseases, Infectious Sarcomastigophora Infections Antirheumatic Agents |