NCT00765024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

September 30, 2008

Last Update Submit

September 3, 2017

Conditions

Chronic Strongyloidiasis

Keywords

strongyloidiasis, ivermectin, albendazole

Outcome Measures

Primary Outcomes (1)

  • cure rate

    1 year

Secondary Outcomes (1)

  • safety

    1 year

Study Arms (3)

Albendazole

ACTIVE COMPARATOR

Albendazole for 7 days

Drug: Albendazole

ivermectin

EXPERIMENTAL

ivermectin 200 mcg/kg single dose

Drug: Ivermectin

ivermectin 2 doses

EXPERIMENTAL

ivermectin 200 mcg/kg two doses in 2 weeks

Drug: ivermectin

Interventions

ivermectinDRUG

single dose of 200 mcg/kg

Also known as: stromectal
ivermectin
AlbendazoleDRUG

Albendazole 7 days

Albendazole

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with positive strongyloides larva in the stool

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 21572981DERIVED

MeSH Terms

Conditions

Strongyloidiasis

Interventions

IvermectinAlbendazole

Condition Hierarchy (Ancestors)

Rhabditida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yupin Suputtamongkol, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

TH(1)