Leishmaniasis; American, CutaneousPhase 2NCT03084952
Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients
A Phase 2 study testing 18-Methoxycoronaridine and Glucantime in people with Leishmaniasis; American, Cutaneous and Drug Side Effect, run by Infan Industria Quimica Farmaceutica Nacional.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Leishmaniasis; American, Cutaneous, Drug Side Effect
- What is being tested?
- 18-Methoxycoronaridine and Glucantime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Being tested
- 18-Methoxycoronaridine, Glucantime
- Keywords
- safety, pharmacokynetics, leishmaniasis treatment
- Medical subject headings
- Leishmaniasis, Mucocutaneous, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-MethoxycoronaridineDrug
Drug under evaluation for leishmaniasis treatment
GlucantimeDrug
Leishmaniasis standard drug in Brazil
| Study group | Role | What they receive |
|---|---|---|
| 1 mg/day | Experimental | Not described Receives: Drug: 18-Methoxycoronaridine |
| 4 mg/day | Experimental | Not described Receives: Drug: 18-Methoxycoronaridine |
| 8 mg/day | Experimental | Not described Receives: Drug: 18-Methoxycoronaridine |
| 12 mg/day | Experimental | Not described Receives: Drug: 18-Methoxycoronaridine |
| Glucantime | Active comparator | Not described Receives: Drug: Glucantime |
| Best dose 18-MC | Experimental | Not described Receives: Drug: 18-Methoxycoronaridine |
| Minimum effective dose 18-MC | Experimental | Not described Receives: Drug: 18-Methoxycoronaridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Reduction and Re-epithelization - Definitive Cure
complete epithelization of all ulcers and complete disappearance of inflammatory hardening of all lesions at 6 months at the follow-up visit.
Measured: 6 months at the follow-up visit.
Lesion Reduction and Re-epithelization - Partial Cure
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.
Measured: 6 months at the follow-up visit.
Clinical Failure
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.
Measured: 6 months at the follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startMay 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis; American, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infan Industria Quimica Farmaceutica Nacional
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084952
- Sponsor's protocol ID
- HB/F2-002/2016
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03084952
- Acronym / sponsor ID
- HB/F2-002/2016
- Keywords
- safety, pharmacokynetics, leishmaniasis treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Infan Industria Quimica Farmaceutica NacionalIndustry (pharma, biotech, devices)
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 mg/day | Experimental | Drug: 18-Methoxycoronaridine |
| 4 mg/day | Experimental | Drug: 18-Methoxycoronaridine |
| 8 mg/day | Experimental | Drug: 18-Methoxycoronaridine |
| 12 mg/day | Experimental | Drug: 18-Methoxycoronaridine |
| Glucantime | Active comparator | Drug: Glucantime |
| Best dose 18-MC | Experimental | Drug: 18-Methoxycoronaridine |
| Minimum effective dose 18-MC | Experimental | Drug: 18-Methoxycoronaridine |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-MethoxycoronaridineDrug under evaluation for leishmaniasis treatment | Drug | 1 mg/day, 12 mg/day, 4 mg/day, 8 mg/day, Best dose 18-MC, Minimum effective dose 18-MC |
| GlucantimeLeishmaniasis standard drug in Brazil | Drug | Glucantime |
Primary outcome
Lesion Reduction and Re-epithelization - Definitive Cure
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18-Methoxycoronaridine and Glucantime in people with Leishmaniasis; American, Cutaneous and Drug Side Effect, run by Infan Industria Quimica Farmaceutica Nacional.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Carlo Delorenzi, PhD (+55(11)989780869, jancarlo@hebron.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Reduction and Re-epithelization - Definitive Cure (time frame: 6 months at the follow-up visit.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.