Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients
NCT03084952 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2020-03-19
Summary
It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.
Conditions
- Leishmaniasis; American, Cutaneous
- Drug Side Effect
Interventions
- DRUG
-
18-Methoxycoronaridine
Drug under evaluation for leishmaniasis treatment
- DRUG
-
Glucantime
Leishmaniasis standard drug in Brazil
Sponsors & Collaborators
-
Infan Industria Quimica Farmaceutica Nacional
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-31
- Primary Completion
- 2023-12-31
- Completion
- 2024-07-31
More Related Trials
-
Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis
NCT01380314 ·Status: COMPLETED ·Phase: PHASE2
-
Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
NCT00317629 ·Status: TERMINATED ·Phase: PHASE3
-
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
NCT00257530 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
NCT06997159 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Short Course of Miltefosine and Antimony to Treat Cutaneous Leishmaniasis in Bolivia
NCT00537953 ·Status: UNKNOWN ·Phase: PHASE2
-
Low Antimonial Dosage in American Mucosal Leishmaniasis
NCT01301937 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
NCT00469495 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
NCT04340128 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
NCT00111553 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
NCT00317980 ·Status: COMPLETED ·Phase: PHASE4
-
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
NCT01032187 ·Status: COMPLETED ·Phase: PHASE4
-
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
NCT00973128 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis
NCT02919605 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
NCT03874234 ·Status: TERMINATED ·Phase: PHASE1
-
Miltefosine and GM-CSF in Cutaneous Leishmaniasis
NCT03023111 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
NCT01301924 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica
NCT00351520 ·Status: COMPLETED ·Phase: PHASE3
-
Liposomal Amphotericin in Disseminated Leishmaniasis
NCT02025491 ·Status: COMPLETED ·Phase: PHASE3
-
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
NCT02429518 ·Status: COMPLETED
-
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
NCT00233545 ·Status: COMPLETED ·Phase: PHASE2
-
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
NCT00703924 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis
NCT00682656 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis with Inhaled Pentamidine Plus Oral Miltefosine
NCT06550609 ·Status: RECRUITING ·Phase: PHASE2
-
Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
NCT00004755 ·Status: COMPLETED ·Phase: PHASE2
-
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
NCT00604955 ·Status: COMPLETED ·Phase: PHASE4