Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

Sponsor

Infan Industria Quimica Farmaceutica Nacional (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT03084952

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leishmaniasis; American, Cutaneous Drug Side Effect	Drug: 18-Methoxycoronaridine Drug: Glucantime	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Randomized, Unicentric Clinical Trial With Dose Scaling for Safety, Tolerability and Efficacy Assessment of 18-Methoxycoronaridine Administered to Cutaneous Leishmaniasis Patients

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 mg/day	Drug: 18-Methoxycoronaridine Drug under evaluation for leishmaniasis treatment
Experimental: 4 mg/day	Drug: 18-Methoxycoronaridine Drug under evaluation for leishmaniasis treatment
Experimental: 8 mg/day	Drug: 18-Methoxycoronaridine Drug under evaluation for leishmaniasis treatment
Experimental: 12 mg/day	Drug: 18-Methoxycoronaridine Drug under evaluation for leishmaniasis treatment
Active Comparator: Glucantime	Drug: Glucantime Leishmaniasis standard drug in Brazil
Experimental: Best dose 18-MC	Drug: 18-Methoxycoronaridine Drug under evaluation for leishmaniasis treatment
Experimental: Minimum effective dose 18-MC	Drug: 18-Methoxycoronaridine Drug under evaluation for leishmaniasis treatment

Outcome Measures

Primary Outcome Measures

Lesion Reduction and Re-epithelization - Definitive Cure [6 months at the follow-up visit.]
complete epithelization of all ulcers and complete disappearance of inflammatory hardening of all lesions at 6 months at the follow-up visit.
Lesion Reduction and Re-epithelization - Partial Cure [6 months at the follow-up visit.]
incomplete epithelialization or incomplete regression of inflammatory hardening of one or more lesions, and without the appearance of new lesions. Apparent cure: complete epithelization of all ulcers and regression ≥ 70% of the inflammatory hardening of all lesions.
Clinical Failure [6 months at the follow-up visit.]
Any of the following topics as clinical failure: residual readers with the presence of non-GiemsaDiff-Quick print parasites, or the appearance of new lesions or ≥ 20% increase or no improvement of lesions previously documented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 59 years of age;
Clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month;
Parasitological confirmation;
Women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-HCG (Gonadotrophic-Chorionic Hormone beta) at the time of screening;
Men and women should use barrier contraceptive methods during the course of the study;

Exclusion Criteria:

History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
History of cancer;
History of drug abuse, judging by the investigator
History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
History of smoking
History of severe allergy / hypersensitivity, judged by the investigator;
History of hypersensitivity to drugs with similar chemical structure.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Infan Industria Quimica Farmaceutica Nacional

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Infan Industria Quimica Farmaceutica Nacional

ClinicalTrials.gov Identifier:

NCT03084952

Other Study ID Numbers:

HB/F2-002/2016

First Posted:

Mar 21, 2017

Last Update Posted:

Mar 19, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Infan Industria Quimica Farmaceutica Nacional

safety

pharmacokynetics

leishmaniasis treatment

Additional relevant MeSH terms:

Leishmaniasis

Leishmaniasis, Cutaneous

Meglumine Antimoniate

Study Results

No Results Posted as of Mar 19, 2020