Safety and Efficacy of Drug Combinations Against Trichuris Trichiura
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.
2 other identifiers
interventional
750
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedJanuary 15, 2010
January 1, 2010
1.8 years
January 22, 2008
January 14, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Record adverse reactions
6 weeks
Secondary Outcomes (1)
Efficacy of treatment
6 weeks
Study Arms (5)
1
PLACEBO COMPARATORalbendazole treatment
2
ACTIVE COMPARATORmebendazole treatment
3
ACTIVE COMPARATORivermectin treatment
4
ACTIVE COMPARATORalbendazole + ivermectin treatment
5
ACTIVE COMPARATORmebendazole + ivermectin treatment
Interventions
albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)
mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)
Eligibility Criteria
You may qualify if:
- Those who are enrolled in class one to six
- Are infected with T. trichiura
- Whose parent consent and who are willing to participate
You may not qualify if:
- Those with acute and chronic diseases other than T. trichiura
- Those with a history of any serious adverse drug reactions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vector Control Division
Kampala, Uganda
Related Publications (1)
Namwanje H, Kabatereine NB, Olsen A. Efficacy of single and double doses of albendazole and mebendazole alone and in combination in the treatment of Trichuris trichiura in school-age children in Uganda. Trans R Soc Trop Med Hyg. 2011 Oct;105(10):586-90. doi: 10.1016/j.trstmh.2011.07.009. Epub 2011 Aug 31.
PMID: 21885077DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 22, 2008
First Posted
January 15, 2010
Study Start
October 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
January 15, 2010
Record last verified: 2010-01