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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01529710
Other study ID # Mirazid2012
Secondary ID
Status Completed
Phase Phase 3
First received February 6, 2012
Last updated February 19, 2015
Start date December 2011
Est. completion date September 2012

Study information

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 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Myrrh
Subjects 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.

Locations

Country Name City State
Egypt Tanta Health Unit Gharbiya
Egypt Health Unit of Atfeeh Giza

Sponsors (1)

Lead Sponsor Collaborator
Pharco Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome

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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