Status:
COMPLETED
Evaluation of Praziquantel Dosage for Treatment of Schistosomiasis in Brazil
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborating Sponsors:
World Health Organization
Universidade Federal de Pernambuco
Conditions:
Schistosomiasis Mansoni
Eligibility:
All Genders
10-19 years
Phase:
PHASE4
Brief Summary
The primary objective of this project is to evaluate the efficacy and safety of praziquantel 60 mg/kg in the treatment of schistosomiasis, as compared to the standard 40 mg/kg therapy in a representat...
Detailed Description
This is a double blind, randomized, PZQ 40mg/Kg- controlled clinical trial. Subjects 10-19 years old living in communities of the Northeast of Brazil will be identified and invited to participate in t...
Eligibility Criteria
Inclusion
- Persons with 10-19 years of age harbouring at least 100 epg who are able and willing to follow-up and provide a written informed consent will participate in the study
Exclusion
- Pregnancy or lactation
- Acute or chronic severe diseases including hepato-splenic schistosomiasis
- Use of praziquantel in the last 30 days
- Known hypersensitivity associated with praziquantel
- Current use of other medication that may affect the results of the present trial, such as antibiotics and corticosteroids, and any medical condition that on the judgement of the physician makes subject participation impossible.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00403611
Start Date
March 1 2006
End Date
May 1 2008
Last Update
June 17 2015
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