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
About this trial
This is an interventional treatment trial for Chronic Strongyloidiasis focused on measuring strongyloidiasis, ivermectin, albendazole
Eligibility Criteria
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
NCT ID
NCT00765024
First Posted
September 30, 2008
Last Updated
September 3, 2017
Sponsor
Mahidol University
Collaborators
Atlantic Laboratory Ltd
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
Learn more about this trial
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
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