CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
iOWH032 +3 moredrug
Likely dose
Antibiotics 500 mgfrom 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/NCT04150250
NCT04150250Phase 2Completed
CompareCT.gov

A Phase 2a Randomized, Single-Center, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Preliminary Efficacy of Oral iOWH032 Against Cholera Diarrhea in a Controlled Human Infection Model

PATH·interventional·Posted Nov 4, 2019·Updated Mar 25, 2021

In Brief

A Phase 2 clinical trial evaluating iOWH032, Placebo, and 2 other interventions for Cholera. Completed, enrolled 47 participants across 1 site.

Detailed Summary

This trial was designed to assess safety and preliminary efficacy of oral doses of iOWH032 on diarrhea output and clinical symptoms after a cholera challenge in healthy adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholera
CountriesUnited States
CollaboratorsUniversity of Maryland, Baltimore, Pharmaron

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 4, 2019
Enrollment StartNov 4, 2019
Primary CompletionJul 27, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.7 years ago

Interventions

iOWH032drug

Anti-secretory synthetically manufactured small molecule designed to inhibit the cystic fibrosis transmembrane conductance regulator chloride channel.

Placebodrug

Oral tablets matching iOWH032 on taste, appearance, dissolution time with the same excipients but no active ingredients.

V. cholerae Challengeother

Freshly-harvested, wild-type Vibrio (V.) cholerae El Tor Inaba strain N16961,10\^6 cfu suspended in 30 mL of sodium bicarbonate solution ingested orally.

Antibioticsdrug

Antibiotic therapy may include: * Ciprofloxacin 500 mg, twice daily; * Azithromycin 500 mg, once daily (for those persons who are allergic to fluoroquinolones); * Doxycycline 300 mg, once daily (for those persons who are allergic to fluoroquinolones)