Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

NCT ID: NCT01050452

Last Updated: 2010-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parasitic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

albendazole treatment

Group Type PLACEBO_COMPARATOR

albendazole

Intervention Type DRUG

albendazole (400 mg on dose)

2

mebendazole treatment

Group Type ACTIVE_COMPARATOR

mebendazole

Intervention Type DRUG

mebendazole (500 mg one dose)

3

ivermectin treatment

Group Type ACTIVE_COMPARATOR

ivermectin

Intervention Type DRUG

ivermectin (200 microgram/kg body weight)

4

albendazole + ivermectin treatment

Group Type ACTIVE_COMPARATOR

albendazole + ivermectin

Intervention Type DRUG

albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)

5

mebendazole + ivermectin treatment

Group Type ACTIVE_COMPARATOR

mebendazole + ivermectin

Intervention Type DRUG

mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)

Interventions

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albendazole

albendazole (400 mg on dose)

Intervention Type DRUG

mebendazole

mebendazole (500 mg one dose)

Intervention Type DRUG

ivermectin

ivermectin (200 microgram/kg body weight)

Intervention Type DRUG

albendazole + ivermectin

albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)

Intervention Type DRUG

mebendazole + ivermectin

mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DBL -Institute for Health Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Vector control division, Ministry of Health

Locations

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Vector Control Division

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 21885077 (View on PubMed)

Other Identifiers

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DBL-CHRD

Identifier Type: -

Identifier Source: secondary_id

AO.UGA.TRI

Identifier Type: -

Identifier Source: org_study_id

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