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Safety and Efficacy of Mirazid for Schistosomiasis Treatment (PHAR0211)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529710
First Posted: February 9, 2012
Last Update Posted: February 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pharco Pharmaceuticals
February 6, 2012
February 9, 2012
February 20, 2015
December 2011
September 2012   (Final data collection date for primary outcome measure)
Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species. [ Time Frame: 9 months ]
Same as current
Complete list of historical versions of study NCT01529710 on ClinicalTrials.gov Archive Site
Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel. [ Time Frame: 9 months ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Mirazid for Schistosomiasis Treatment
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 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schistosoma Hematobium Infection
  • Schistosomiasis Mansoni
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:
  • Mirazid
  • Praziquantel
  • Shistosomiasis
  • Oral
  • 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.
    Intervention: Drug: Myrrh
  • Active Comparator: Praziquantel
    Tablets
    Intervention: Drug: Myrrh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2012
September 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
15 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT01529710
Mirazid2012
Yes
Not Provided
Not Provided
Pharco Pharmaceuticals
Pharco Pharmaceuticals
Not Provided
Principal Investigator: Ayat A Haggag, MD Netherlands: Ministry of Health, Welfare and Sports
Pharco Pharmaceuticals
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP