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Ivermectin Versus Albendazole for Chronic Strongyloidiasis

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Atlantic Laboratory Ltd
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00765024
First received: September 30, 2008
Last updated: June 18, 2010
Last verified: September 2008
History of Changes
  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: Ivermectin
Drug: ivermectin
Drug: Albendazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Resource links provided by NLM:

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: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Atlantic Laboratory Ltd
Investigators
Principal Investigator: Yupin Suputtamongkol, MD Mahidol University
  More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mahidol University, Faculty of Medicine Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00765024     History of Changes
Other Study ID Numbers: TM001-2008
Study First Received: September 30, 2008
Last Updated: June 18, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
strongyloidiasis, ivermectin, albendazole

Additional relevant MeSH terms:
Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
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

ClinicalTrials.gov processed this record on June 17, 2013