Clinical trial NCT03084952: Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leishmaniasis; American, Cutaneous
Drug Side Effect
Keywords: safety
pharmacokynetics
leishmaniasis treatment
Lead sponsor: Infan Industria Quimica Farmaceutica Nacional
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lesion Reduction and Re-epithelization - Definitive Cure
timeFrame: 6 months at the follow-up visit.
measure: Lesion Reduction and Re-epithelization - Partial Cure
timeFrame: 6 months at the follow-up visit.
measure: Clinical Failure
timeFrame: 6 months at the follow-up visit.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: