Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

This study has been completed.
Sponsor:
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT01050452
First received: January 22, 2008
Last updated: January 14, 2010
Last verified: January 2010
  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 Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050452

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

No publications provided by DBL -Institute for Health Research and Development

Additional 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
Study First Received: January 22, 2008
Last Updated: January 14, 2010
Health Authority: Uganda: Ministry of Health

Additional relevant MeSH terms:
Parasitic Diseases
Albendazole
Mebendazole
Piperazine
Piperazine citrate
Ivermectin
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents

ClinicalTrials.gov processed this record on July 22, 2014