Schistosomiasis Mansoni Clinical Trial
— PHAR0211Official title:
Safety and Efficacy of Mirazid for Schistosomiasis Treatment as Compared to Praziquantel: An Open-label Randomized Non-placebo-Controlled Study
Verified date | February 2015 |
Source | Pharco Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Health and Population |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 30 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta Health Unit | Gharbiya | |
Egypt | Health Unit of Atfeeh | Giza |
Lead Sponsor | Collaborator |
---|---|
Pharco Pharmaceuticals |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species. | 9 months | No | |
Secondary | Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel. | 9 months | Yes |
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