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NCT01050374 Clinical Trial

Safety and Efficacy of Drug Combinations Against Schistosomiasis

Parasitic Diseases Clinical Trial

Official title:
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Praziquantel Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01050374
Other study ID # AO.UGA.PZQ
Secondary ID DBL-CHRD
Status Completed
Phase N/A
First received January 23, 2008
Last updated January 14, 2010
Start date October 2007
Est. completion date October 2008

Study information
Verified date January 2010
Source DBL -Institute for Health Research and Development
Contact n/a
Is FDA regulated No
Health authority Uganda: Ministry of Health
Study type Interventional

Clinical Trial Summary

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15 years of age.

Recruitment information / eligibility
Status Completed
Enrollment 650
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 15 Years
Eligibility Inclusion Criteria:

- Those with an age of 1-15 years of age

- Are infected with schistosomiasis and soil-transmitted helminthiasis

- Whose parent consent and who are willing to participate

Exclusion Criteria:

- Those with acute and chronic diseases other than schistosomiasis and soil-transmitted helminthiasis

- Those with a history of any serious adverse drug reactions

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• albendazole + praziquantel
albendazole (400 mg one dose) + praziquantel (40 mg/kg body weight)
• mebendazole + praziquantel
mebendazole (500 mg one dose) + praziquantel (40 mg/kg body weight)

Locations
Country Name City State
Uganda Vector Control Division Kampala

Sponsors (1)
Lead Sponsor Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of treatment 6 weeks No
Secondary Record of adverse reactions 6 weeks Yes
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