Safety and Efficacy of Mirazid for Schistosomiasis Treatment

NCT01529710 | Completed Phase 3 DMC

• 1 other identifier: Mirazid2012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Schistosoma Hematobium Infection; Schistosomiasis Mansoni

Keywords

Schistosomiasis hematobium; Schistosomiasis mansoni

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.

  9 months

Study Arms (2)

Mirazid

EXPERIMENTAL

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

Praziquantel

ACTIVE COMPARATOR

Tablets

Drug: Myrrh

Interventions

Myrrh 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.

Also known as: Mirazid, Praziquantel, Shistosomiasis, Oral

Mirazid; Praziquantel

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent and young adults aged 15-30 years
• Positive for Schistosoma infection of any type.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharco Pharmaceuticals: lead

Study Sites (2)

Tanta Health Unit

Gharbiya, Egypt

Location

Health Unit of Atfeeh

Giza, Egypt

Location

MeSH Terms

Conditions

Schistosomiasis haematobia; Schistosomiasis mansoni

Interventions

myrrh resin; Praziquantel

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Urinary Tract Infections; Vector Borne Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ayat A Haggag, MD

  Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

EG (2)