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Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Primary Purpose

Chronic Strongyloidiasis

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Ivermectin
ivermectin
Albendazole
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Strongyloidiasis focused on measuring strongyloidiasis, ivermectin, albendazole

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with positive strongyloides larva in the stool

Exclusion Criteria:

  • Pregnancy
  • Lactating women
  • Known allergy to any study drug

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Albendazole

ivermectin

ivermectin 2 doses

Arm Description

Albendazole for 7 days

ivermectin 200 mcg/kg single dose

ivermectin 200 mcg/kg two doses in 2 weeks

Outcomes

Primary Outcome Measures

cure rate

Secondary Outcome Measures

safety

Full Information

First Posted
September 30, 2008
Last Updated
September 3, 2017
Sponsor
Mahidol University
Collaborators
Atlantic Laboratory Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00765024
Brief Title
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Official Title
Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Atlantic Laboratory Ltd

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Strongyloidiasis
Keywords
strongyloidiasis, ivermectin, albendazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albendazole
Arm Type
Active Comparator
Arm Description
Albendazole for 7 days
Arm Title
ivermectin
Arm Type
Experimental
Arm Description
ivermectin 200 mcg/kg single dose
Arm Title
ivermectin 2 doses
Arm Type
Experimental
Arm Description
ivermectin 200 mcg/kg two doses in 2 weeks
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
stromectal
Intervention Description
single dose of 200 mcg/kg
Intervention Type
Drug
Intervention Name(s)
ivermectin
Other Intervention Name(s)
stromectal
Intervention Description
two single dose of 200mcg/kg in 2 weeks
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
Albendazole 7 days
Primary Outcome Measure Information:
Title
cure rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with positive strongyloides larva in the stool Exclusion Criteria: Pregnancy Lactating women Known allergy to any study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yupin Suputtamongkol, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
21572981
Citation
Suputtamongkol Y, Premasathian N, Bhumimuang K, Waywa D, Nilganuwong S, Karuphong E, Anekthananon T, Wanachiwanawin D, Silpasakorn S. Efficacy and safety of single and double doses of ivermectin versus 7-day high dose albendazole for chronic strongyloidiasis. PLoS Negl Trop Dis. 2011 May 10;5(5):e1044. doi: 10.1371/journal.pntd.0001044.
Results Reference
derived

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Ivermectin Versus Albendazole for Chronic Strongyloidiasis

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