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Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

Primary Purpose

Parasitic Diseases

Status

Completed

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

albendazole

mebendazole

ivermectin

albendazole + ivermectin

mebendazole + ivermectin

About this trial

This is an interventional treatment trial for Parasitic Diseases

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vector Control Division

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

albendazole treatment

mebendazole treatment

ivermectin treatment

albendazole + ivermectin treatment

mebendazole + ivermectin treatment

Outcomes

Primary Outcome Measures

Record adverse reactions

Secondary Outcome Measures

Efficacy of treatment

Full Information

NCT ID

NCT01050452

First Posted

January 22, 2008

Last Updated

January 14, 2010

Sponsor

DBL -Institute for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01050452

Brief Title

Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

DBL -Institute for Health Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parasitic Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

albendazole treatment

Arm Title

Arm Type

Active Comparator

Arm Description

mebendazole treatment

Arm Title

Arm Type

Active Comparator

Arm Description

ivermectin treatment

Arm Title

Arm Type

Active Comparator

Arm Description

albendazole + ivermectin treatment

Arm Title

Arm Type

Active Comparator

Arm Description

mebendazole + ivermectin treatment

Intervention Type

Drug

Intervention Name(s)

albendazole

Intervention Description

albendazole (400 mg on dose)

Intervention Type

Drug

Intervention Name(s)

mebendazole

Intervention Description

mebendazole (500 mg one dose)

Intervention Type

Drug

Intervention Name(s)

ivermectin

Intervention Description

ivermectin (200 microgram/kg body weight)

Intervention Type

Drug

Intervention Name(s)

albendazole + ivermectin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

mebendazole + ivermectin

Intervention Description

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

Primary Outcome Measure Information:

Title

Record adverse reactions

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Efficacy of treatment

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Vector Control Division

City

Kampala

Country

Uganda

12. IPD Sharing Statement

Citations:

PubMed Identifier

21885077

Citation

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.

Results Reference

derived

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Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

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