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NCT00351520
Phase 3, Clinical Trials of Drug Against Cutaneous Leishmaniasis
Phase 3 trial testing Miltefose in Cutaneous Leishmaniasis in 148 participants. Completed in 1 June 2007.
Quick facts
| Lead sponsor | Tehran University of Medical Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 1 May 2006 |
| Estimated completion | 1 June 2007 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Miltefose — full drug profile →
Conditions studied
- Cutaneous Leishmaniasis — all drugs for Cutaneous Leishmaniasis →
Sponsor
Tehran University of Medical Sciences
Who can join
Adults 12 to 60, any sex, with Cutaneous Leishmaniasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Complete re-epithelization of the lesion(s)
Sponsor's own description
Cutaneous leishmaniasis is a parasitic skin lesion caused by different species of Leishmania and transmitted by the bite of infected sand flies. Leishmaniasis is exist in 88 countries, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for this disease for last 80 years. Pentavalent antimonials are only available as injectable, which is painful, toxic, not affordable and moreover is not always effective even sometimes with several courses of treatment. Many different modalities are used to treat the disease with little success. Miltefosine is drug and has recently been shown to be effective in the treatment cutaneous leishmaniasis in Colombia. The molecular mechanisms that contribute to this effectiveness are not clearly understood. Only a well designed, randomized clinical trial can precisely evaluate the efficacy of any therapeutic modalities in cutaneous leishmaniasis. In this study the efficacy of oral treatment of miltefosine 2.5 mg per Kg body weight for 4 weeks will be compared with standard treatment of intramuscular injections of 60 mg/kg/day glucantime for 2 weeks in ACL parasitologically proven patients. At 8 weeks after the initiation of the treatment any patient in the group who received miltefosine and has not responded to the treatment will be treated with the standard intramuscular injections of 60 mg/kg/day glucantime for 2 weeks. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00351520
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cutaneous Leishmaniasis
Currently open trials in the same condition.
- NCT06798415 — Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis · Phase 2 · recruiting
- NCT06797544 — Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis · Phase 2 · recruiting
- NCT06798402 — Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate · Phase 2 · recruiting
Other Tehran University of Medical Sciences trials
Trials by the same sponsor.
- NCT07305883 — Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain · Phase 3 · not yet recruiting
- NCT06876194 — The Effect of Music on the Sedation Quality Among Children in the Emergency Department. · Phase 3 · completed
- NCT06721273 — Iodine Supplementation and Fertility Parameters · NA · not yet recruiting
- NCT07014397 — Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth · NA · completed
- NCT06615934 — Effects of Aerobic and Resistance Exercises on Inpatients Liver Transplantation Recipients · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00351520 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tehran University of Medical Sciences
- Last refreshed: 19 September 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00351520.
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