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Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT00765024
Collaborator
Atlantic Laboratory Ltd (Other)
90
Enrollment
1
Location
3
Arms
21
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Jul 1, 2008
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • stromectal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cure rate [1 year]

    Secondary Outcome Measures

    1. safety [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with positive strongyloides larva in the stool
    Exclusion Criteria:

    • Pregnancy

    • Lactating women

    • Known allergy to any study drug

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siriraj Hospital Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University
    • Atlantic Laboratory Ltd

    Investigators

    • Principal Investigator: Yupin Suputtamongkol, MD, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT00765024
    Other Study ID Numbers:
    • TM001-2008
    First Posted:
    Oct 2, 2008
    Last Update Posted:
    Sep 7, 2017
    Last Verified:
    Sep 1, 2017
    Keywords provided by Mahidol University
    strongyloidiasis, ivermectin, albendazole
    Additional relevant MeSH terms:
    Strongyloidiasis
    Ivermectin
    Albendazole

    Study Results

    No Results Posted as of Sep 7, 2017