CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 617 enrolled
Drug / intervention
Moxidectin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04056325
NCT04056325Phase 3Completed

Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Moxidectin Alone and in Comparison to Ivermectin Against Strongyloides Stercoralis in Adults: a Randomized Controlled Trial

Jennifer Keiser·interventional·Posted Aug 14, 2019·Updated Dec 9, 2024

In Brief

A Phase 3 clinical trial evaluating Moxidectin, Ivermectin, and 1 other intervention for Strongyloides Stercoralis Infection. Completed, enrolled 617 participants across 1 site.

Detailed Summary

This study is a phase 2, blinded and randomized clinical trial. The phase 2a trial is single blinded and conducted in Lao, while the phase 2b trial is double-blinded and conducted in Lao and Cambodia. The study aims at providing evidence on effective doses and safety of moxidectin in adults against infection with S. stercoralis in Laos (trial 2a) and efficacy and safety of moxidectin compared to ivermectin in adults against infection with S. stercoralis in Laos and Cambodia (trial 2b). The efficacy of the treatment will be assessed by collecting three stool samples once pre-treatment and once 21 days post-treatment. The stool samples will be analyzed by a quantitative Baermann assay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesLaos

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 14, 2019
Enrollment StartNov 27, 2019
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.9 years ago

Interventions

Moxidectindrug

Monotherapy, oral administration, single dose, fixed dose

Ivermectindrug

Monotherapy, oral administration, single dose, weight dependent

Placebo oral tabletdrug

Monotherapy, oral administration, single dose, matching number of tablets