Safety and Efficacy of Mirazid for Schistosomiasis Treatment (PHAR0211)

Safety and Efficacy of Mirazid for Schistosomiasis Treatment as Compared to Praziquantel: An Open-label Randomized Non-placebo-Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Schistosomiasis Mansoni; Schistosoma Hematobium Infection
• Intervention / Treatment: Drug: Myrrh

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya, Egypt
    • Tanta Health Unit
  • Giza, Egypt
    • Health Unit of Atfeeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Oral; Praziquantel; Mirazid; Shistosomiasis
Active Comparator: Praziquantel; Tablets	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.; Other Names: Oral; Praziquantel; Mirazid; Shistosomiasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.	9 months

Collaborators and Investigators

• Sponsor: Pharco Pharmaceuticals
• Investigators: Principal Investigator: Ayat A Haggag, MD, Ministry of Health

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimate): February 9, 2012

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Schistosomiasis hematobium; Schistosomiasis mansoni
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Vector Borne Diseases; Parasitic Diseases; Helminthiasis; Urinary Tract Infections; Trematode Infections; Schistosomiasis; Schistosomiasis mansoni; Schistosomiasis haematobia; Anti-Infective Agents; Antiparasitic Agents; Anthelmintics; Praziquantel
• Other Study ID Numbers: Mirazid2012