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Trial record 84 of 103 for:    IVERMECTIN

Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

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ClinicalTrials.gov Identifier: NCT01050452
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Sponsor:
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

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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 ]


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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Ivermectin
Parasitic Diseases
Albendazole
Mebendazole
Piperazine
Piperazine citrate
DMP 777
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents
Enzyme Inhibitors