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CAST: iOWH032 for Cholera Diarrhea
NCT04150250Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2019
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- PATH
- Modality
- Small Molecules
- Drugs
- IOWH-032
- Conditions
- cholera
01
Overview
Phase 2, randomised, double-blind trial in cholera comparing iOWH032 with Placebo (2 arms). Primary endpoints: Diarrheal Stool Output Rate and Number of Participants With Treatment-emergent Serious Adverse Events. Started Nov 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
iOWH032
iOWH032 500 mg q8h x 3 days
Placebo
Matching Placebo q8h x 3 days
03
Who it enrols
Healthy adults aged 18-44 with no history of cholera or recent travel to endemic areas, and no significant medical history.
04
Endpoints
Primary
Diarrheal Stool Output Rate
Number of Participants With Treatment-emergent Serious Adverse Events
Secondary
Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge
Attack Rate of Any Diarrhea Following Cholera Challenge
Area Under the Curve (AUC) of Diarrheal Stool Volume Between Challenge Dose and Initiation of Antibiotics
Peak Shedding of Cholera Organisms
Duration of Diarrheal Episodes
Total Number of Loose (Grade 3-5) Stools
Percentage of Participants With Fever Following Cholera Challenge
Percentage of Participants With Vomiting Following Cholera Challenge
05
Results
Not all primary endpoints met
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