Safety and Efficacy of Mirazid for Schistosomiasis Treatment
Information source: Pharco Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schistosoma Hematobium Infection; Schistosomiasis Mansoni
Intervention: Myrrh (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pharco Pharmaceuticals Official(s) and/or principal investigator(s): Ayat A Haggag, MD, Principal Investigator, Affiliation: Netherlands: Ministry of Health, Welfare and Sports
Summary
Clinical Trial Phase: Phase III
Primary Objectives:
- Compare Mirazid and Praziquantel cure rates for both Schistosoma species.
- Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both
Schistosoma species.
Secondary Objective: Identify and compare the types and severity of side and adverse effects
between the Mirazid and Praziquantel.
Study Population: 200 Schistosomiasis infected persons of both types of Schistosomiasis aged
from 15-35 years. Those subjects will be selected from among those screened. Subjects will
include both genders excluding chronically ill such as chronic liver disease patients and
those with both types of Schistosomiasis.
Recruitment Period: 3 months and subjects follow up for another 3 months followed by 3 months
for statistical analysis and report writing Study Duration: Total study duration is expected
to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data
management and report writing.
Endpoints: Will be measured at 3 months of successful administration of treatment either
Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the
response to treatment will be done by examining urine or stool of the subject for presence
of Schistosoma eggs and its density if found.
Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will
indicate treatment success. One positive sample collected at week 12 will indicate infection
with Schistosomiasis.
Clinical Details
Official title: Safety and Efficacy of Mirazid for Schistosomiasis Treatment as Compared to Praziquantel: An Open-label Randomized Non-placebo-Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species.
Secondary outcome: Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.
Detailed description:
Study Design: This is a phase III, open-label randomized non-placebo-controlled Study in
which the investigators will compare the efficacy and safety of Mirazid to Praziquantel as a
treatment for Schistosomiasis. After screening, positive subjects for one of the
Schistosomiasis will be recruited in the study. They will be treated by Mirazid as 600 mg
oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel
as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of
treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis
including egg counts for the positive cases.
Eligibility
Minimum age: 15 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adolescent and young adults aged 15-30 years
- Positive for Schistosoma infection of any type.
Exclusion Criteria:
- Mixed Schistosoma infection of both types
- History of administration of treatment for Schistosoma infection in the last 6
months prior to the study.
- Severely ill patients
- Advanced chronic liver disease.
Locations and Contacts
Tanta Health Unit, Gharbiya, Egypt
Health Unit of Atfeeh, Giza, Egypt
Additional Information
Starting date: December 2011
Last updated: February 19, 2015
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