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Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050452
First Posted: January 15, 2010
Last Update Posted: January 15, 2010
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.
Information provided by:
DBL -Institute for Health Research and Development
  Purpose
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 Intervention
Parasitic Diseases Drug: albendazole Drug: mebendazole Drug: ivermectin Drug: albendazole + ivermectin Drug: mebendazole + ivermectin

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

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

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

Estimated Enrollment: 750
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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.


Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01050452


Locations
Uganda
Vector Control Division
Kampala, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harriet Namwanje Principal Investigator, Vector control division, Ministry of Health
ClinicalTrials.gov Identifier: NCT01050452     History of Changes
Other Study ID Numbers: AO.UGA.TRI
DBL-CHRD
First Submitted: January 22, 2008
First Posted: January 15, 2010
Last Update Posted: January 15, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Parasitic Diseases
Albendazole
Mebendazole
Piperazine citrate
Piperazine
Ivermectin
Anthelmintics
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