Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480883
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2007-05-29
Brief Title:
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol
Sponsor:
Combined Military Hospital Pakistan
Organization:
Combined Military Hospital Pakistan
Study Overview
Official Title:
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 MgKgDay Versus Meglumine Antimoniate 10 MgKgDay And Tablet Allopurinol 20 MgKgDay
Status:
COMPLETED
Status Verified Date:
2008-05
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:
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 inclusionexclusion criteria patients will be randomized to receive either meglumine antimoniate 20 mgkgdayintramuscular till clinical resolution or a maximum of 28 days or combination of meglumine antimoniate 10 mgkgday intramuscular and allopurinol 20 mgkgdayoral 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
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 inclusionexclusion criteria patients will be randomized to receive either meglumine antimoniate 20 mgkgdayintramuscular till clinical resolution or a maximum of 28 days or combination of meglumine antimoniate 10 mgkgday intramuscular and allopurinol 20 mgkgdayoral 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None