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Ivermectin Versus Albendazole for Chronic Strongyloidiasis

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.
 
ClinicalTrials.gov Identifier: NCT00765024
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Atlantic Laboratory Ltd
Information provided by (Responsible Party):
Mahidol University

Study Description
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Brief Summary:
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.

Condition or disease Intervention/treatment Phase
Chronic Strongyloidiasis Drug: Ivermectin Drug: ivermectin Drug: Albendazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Actual Study Start Date : July 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Albendazole
Albendazole for 7 days
 Drug: Albendazole
Albendazole 7 days
Experimental: ivermectin
ivermectin 200 mcg/kg single dose
 Drug: Ivermectin
single dose of 200 mcg/kg
Other Name: stromectal
Experimental: ivermectin 2 doses
ivermectin 200 mcg/kg two doses in 2 weeks
 Drug: ivermectin
two single dose of 200mcg/kg in 2 weeks
Other Name: stromectal


Outcome Measures
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Primary Outcome Measures :
  1. cure rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. safety [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with positive strongyloides larva in the stool

Exclusion Criteria:

  • Pregnancy
  • Lactating women
  • Known allergy to any study drug
Contacts and Locations
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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): NCT00765024


Locations
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Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Atlantic Laboratory Ltd
Investigators
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Principal Investigator: Yupin Suputtamongkol, MD Mahidol University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT00765024    
Other Study ID Numbers: TM001-2008
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Keywords provided by Mahidol University:
strongyloidiasis, ivermectin, albendazole
Additional relevant MeSH terms:
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Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Infections
Ivermectin
Albendazole
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