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OpenTrials
Completed

NCT Number: NCT01050452

Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

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.

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Key information

Conditions

Parasitic Diseases Infections

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vector Control Division

Kampala, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole

Drug

albendazole (400 mg on dose)

Mebendazole

Drug

mebendazole (500 mg one dose)

Ivermectin

Drug

ivermectin (200 microgram/kg body weight)

albendazole + ivermectin

Drug

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

mebendazole + ivermectin

Drug

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

Primary outcomes

  1. Record adverse reactions

    Time frame: 6 weeks

Secondary outcomes

  1. Efficacy of treatment

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

DBL -Institute for Health Research and Development

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2010
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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