Safety and Efficacy of Mirazid for Schistosomiasis Treatment

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharco Pharmaceuticals
• Treatments: Praziquantel

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.