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NCT01050452 Clinical Trial

Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

Parasitic Diseases Clinical Trial

Official title:
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01050452
Other study ID # AO.UGA.TRI
Secondary ID DBL-CHRD
Status Completed
Phase N/A
First received January 22, 2008
Last updated January 14, 2010
Start date October 2007
Est. completion date August 2009

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 albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria:

- Those who are enrolled in class one to six

- Are infected with T. trichiura

- Whose parent consent and who are willing to participate

Exclusion Criteria:

- Those with acute and chronic diseases other than T. trichiura

- 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
albendazole (400 mg on dose)
• mebendazole
mebendazole (500 mg one dose)
• ivermectin
ivermectin (200 microgram/kg body weight)
• albendazole + ivermectin
albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)
• mebendazole + ivermectin
mebendazole (500 mg one dose) + ivermectin (200 microgram/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 Record adverse reactions 6 weeks Yes
Secondary Efficacy of treatment 6 weeks No
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