Safety and Efficacy of Mirazid for Schistosomiasis Treatment

NCT ID: NCT01529710

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-09-30

Brief 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.

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.

Conditions

Schistosoma Hematobium Infection; Schistosomiasis Mansoni

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mirazid

Mirazid is an antischistosomal drug available in the local Egyptian market since 2001 (Mirazid®). It originates from Myrrh a medicinal herb that has been used for thousands of years. Myrrh (Arabian or Somali Myrrh) is an oleo-gum resin, obtained from the stem of various species of Commiphora (Burseraceae) growing in northeast Africa and Arabia.

Group Type: EXPERIMENTAL

Myrrh

Intervention Type: DRUG

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.

Praziquantel

Tablets

Group Type: ACTIVE_COMPARATOR

Myrrh

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Mirazid; Praziquantel; Shistosomiasis; Oral

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharco Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayat A Haggag, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Locations

Tanta Health Unit

Gharbiya, , Egypt

Health Unit of Atfeeh

Giza, , Egypt

Countries

Egypt

Other Identifiers

Mirazid2012

Identifier Type: -

Identifier Source: org_study_id