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Ivermectin Versus Albendazole for Chronic Strongyloidiasis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Mahidol University.
Recruitment status was:  Enrolling by invitation
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
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 ]

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

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   (Adult, Senior)
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
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

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

Keywords provided by Mahidol University:
strongyloidiasis, ivermectin, albendazole

Additional relevant MeSH terms:
Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Ivermectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 27, 2017