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Safety and Efficacy of Mirazid for Schistosomiasis Treatment (PHAR0211)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Pharco Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Pharco Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01529710
First received: February 6, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Schistosoma Hematobium Infection
Schistosomiasis Mansoni
Drug: Myrrh
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Mirazid for Schistosomiasis Treatment as Compared to Praziquantel: An Open-label Randomized Non-placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Pharco Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Mirazid
  • Praziquantel
  • Shistosomiasis
  • Oral
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:
  • Mirazid
  • Praziquantel
  • Shistosomiasis
  • Oral

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.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529710

Contacts
Contact: Alaa Abou-Zeid, PhD +2 02 2690 9510 abouzeida@scidreco.com
Contact: Noha Sami, BSc.Pharm. +2 02 2690 9510 samin@scidreco.com

Locations
Egypt
Tanta Health Unit Recruiting
Gharbiya, Egypt
Contact: Ayat A Haggag, MD    +2 02 279 45931    ayatef@yahoo.com   
Principal Investigator: Ayat A Haggag, MD         
Health Unit of Atfeeh Active, not recruiting
Giza, Egypt
Sponsors and Collaborators
Pharco Pharmaceuticals
Investigators
Principal Investigator: Ayat A Haggag, MD Netherlands: Ministry of Health, Welfare and Sports
  More Information

No publications provided

Responsible Party: Pharco Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01529710     History of Changes
Other Study ID Numbers: Mirazid2012
Study First Received: February 6, 2012
Last Updated: February 8, 2012
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Pharco Pharmaceuticals:
Schistosomiasis hematobium
Schistosomiasis mansoni

Additional relevant MeSH terms:
Schistosomiasis
Schistosomiasis haematobia
Schistosomiasis mansoni
Helminthiasis
Infection
Parasitic Diseases
Trematode Infections
Urinary Tract Infections
Urologic Diseases
Praziquantel
Anthelmintics
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014