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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
  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:


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
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: 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
Helminthiasis
Nematode Infections
Parasitic Diseases
Rhabditida Infections
Secernentea Infections
Albendazole
Ivermectin
Anthelmintics
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014