- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00765024
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
September 3, 2017 updated by: Mahidol University
Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Siriraj Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with positive strongyloides larva in the stool
Exclusion Criteria:
- Pregnancy
- Lactating women
- Known allergy to any study drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Albendazole
Albendazole for 7 days
|
Albendazole 7 days
|
|
Experimental: ivermectin
ivermectin 200 mcg/kg single dose
|
single dose of 200 mcg/kg
Other Names:
|
|
Experimental: ivermectin 2 doses
ivermectin 200 mcg/kg two doses in 2 weeks
|
two single dose of 200mcg/kg in 2 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
cure rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
safety
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yupin Suputtamongkol, MD, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
September 30, 2008
First Submitted That Met QC Criteria
September 30, 2008
First Posted (Estimate)
October 2, 2008
Study Record Updates
Last Update Posted (Actual)
September 7, 2017
Last Update Submitted That Met QC Criteria
September 3, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Parasitic Diseases
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Rhabditida Infections
- Strongyloidiasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Ivermectin
- Albendazole
Other Study ID Numbers
- TM001-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Strongyloidiasis
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Central Hospital, Nancy, FranceCompleted
-
Centro per le Malattie TropicaliEuropean CommissionCompletedStrongyloidiasisItaly, Spain, United Kingdom
-
Jennifer KeiserNational Institute of Public Health, Vientiane, LaosCompletedStrongyloides Stercoralis InfectionLao People's Democratic Republic
-
Swiss Tropical & Public Health InstituteNational Institute of Public Health, Vientiane, LaosCompletedStrongyloidiasis | Strongyloides Stercoralis InfectionLao People's Democratic Republic
-
Universidad Nacional de SaltaAlbert B. Sabin Vaccine Institute; Fundación Mundo SanoUnknownHelminthiasis | Strongyloides Stercoralis InfectionArgentina
-
IRCCS Sacro Cuore Don Calabria di NegrarUniversity of Rwanda; Rwanda Biomedical CentreCompletedStrongyloides Stercoralis Infection | StrongyloidesRwanda
-
IRCCS Sacro Cuore Don Calabria di NegrarCompletedStrongyloides Stercoralis InfectionItaly
-
IRCCS Sacro Cuore Don Calabria di NegrarWorld Health Organization; Universidad Central del Ecuador; CECOMET (Centro de...CompletedStrongyloidiasis | Strongyloides Stercoralis InfectionEcuador
-
Imperial College Healthcare NHS TrustUnknownStrongyloidiasis | Bone Marrow Transplant Infection
-
Jennifer KeiserNational Centre for Parasitology, Entomology and Malaria Control, CambodiaCompletedStrongyloides Stercoralis InfectionCambodia
Clinical Trials on Albendazole
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Medicines Development for Global HealthMurdoch Childrens Research Institute; Kirby InstituteNot yet recruitingLymphatic Filariasis | Scabies | StrongyloidiasisFiji
-
Washington University School of MedicineNational Public Health Institute of LiberiaActive, not recruitingOnchocerciasis | Onchocerciasis, Ocular | Tropical Disease | Onchocercal Subcutaneous Nodule | Onchocerca InfectionLiberia
-
London School of Hygiene and Tropical MedicineEmory UniversityTerminated
-
Universidad Nacional de SaltaFundación Mundo SanoNot yet recruitingPharmacological Action
-
GlaxoSmithKlineCompleted
-
Centers for Disease Control and PreventionUniversidad del Valle, GuatemalaCompletedPediculosis | Strongyloidiasis | Ascariasis | Trichuriasis | Hookworm InfectionGuatemala
-
Jennifer KeiserBayer; Centre Suisse de Recherches Scientifiques en Cote d'Ivoire; Université...Not yet recruiting
-
University GhentSwiss Tropical & Public Health InstituteCompletedSoil-transmitted Helminth InfectionsEthiopia, Lao People's Democratic Republic, Brazil, Tanzania
-
Ministry of Health, KyrgyzstanUniversity of ZurichCompleted