Working… Menu

Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050452
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Information provided by:
DBL -Institute for Health Research and Development

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.

Condition or disease Intervention/treatment Phase
Parasitic Diseases Drug: albendazole Drug: mebendazole Drug: ivermectin Drug: albendazole + ivermectin Drug: mebendazole + ivermectin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.
Study Start Date : October 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
albendazole treatment
Drug: albendazole
albendazole (400 mg on dose)

Active Comparator: 2
mebendazole treatment
Drug: mebendazole
mebendazole (500 mg one dose)

Active Comparator: 3
ivermectin treatment
Drug: ivermectin
ivermectin (200 microgram/kg body weight)

Active Comparator: 4
albendazole + ivermectin treatment
Drug: albendazole + ivermectin
albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)

Active Comparator: 5
mebendazole + ivermectin treatment
Drug: mebendazole + ivermectin
mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)

Primary Outcome Measures :
  1. Record adverse reactions [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Efficacy of treatment [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050452

Layout table for location information
Vector Control Division
Kampala, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Harriet Namwanje Principal Investigator, Vector control division, Ministry of Health Identifier: NCT01050452    
Other Study ID Numbers: AO.UGA.TRI
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Parasitic Diseases
Piperazine citrate
DMP 777
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents
Enzyme Inhibitors