Ivermectin Versus Albendazole for Chronic Strongyloidiasis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 30, 2008

Last Updated Date

September 17, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00765024 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Official Title ^ICMJE

Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Strongyloidiasis

Intervention ^ICMJE

Drug: albendazole
Drug: Ivermectin
Drug: ivermectin

Study Arms / Comparison Groups

Experimental: 7-day Albendazole
Active Comparator: ivermectin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with positive strongyloides larva in the stool

Exclusion Criteria:

Pregnancy
Lactating women
Known allergy to any study drug

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00765024

Responsible Party

Mahidol University, Faculty of Medicine Siriraj Hospital

Study ID Numbers ^ICMJE

TM001-2008

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Atlantic Laboratory Ltd

Investigators ^ICMJE

Principal Investigator:

Yupin Suputtamongkol, MD

Faculty of Medicine, Siriraj Hospital, Mahidol University

Information Provided By

Mahidol University

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP