Ivermectin Versus Albendazole for Chronic Strongyloidiasis

This study is enrolling participants by invitation only.

First Received: September 30, 2008 Last Updated: September 17, 2009 History of Changes

Sponsor:	Mahidol University
Collaborator:	Atlantic Laboratory Ltd
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00765024

Purpose

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	Intervention	Phase
Chronic Strongyloidiasis	Drug: albendazole Drug: Ivermectin Drug: ivermectin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Resource links provided by NLM:

Drug Information available for: Albendazole Ivermectin

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

cure rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 7-day Albendazole	Drug: albendazole 400 mg bd.for 7 days
2: Active Comparator ivermectin	Drug: Ivermectin single dose of 200 mcg/kg
3: Experimental	Drug: ivermectin two single dose of 200mcg/kg in 2 weeks

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765024

Locations

Thailand, Bangkok
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Atlantic Laboratory Ltd

Investigators

Principal Investigator:

Yupin Suputtamongkol, MD

Faculty of Medicine, Siriraj Hospital, Mahidol University

More Information

No publications provided

Responsible Party:	Faculty of Medicine Siriraj Hospital ( Mahidol University )
Study ID Numbers:	TM001-2008
Study First Received:	September 30, 2008
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00765024 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

strongyloidiasis, ivermectin, albendazole

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiplatyhelmintic Agents
Mitosis Modulators
Nematode Infections
Anthelmintics
Antimitotic Agents
Pharmacologic Actions
Anticestodal Agents

Albendazole
Strongyloidiasis
Rhabditida Infections
Antiparasitic Agents
Ivermectin
Therapeutic Uses
Tubulin Modulators
Parasitic Diseases
Helminthiasis
Secernentea Infections

ClinicalTrials.gov processed this record on November 30, 2009