Cholera Anti-Secretory Treatment Trial (CAST)
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|ClinicalTrials.gov Identifier: NCT04150250|
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cholera||Drug: iOWH032 Drug: Placebo oral tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||August 2020|
Oral iOWH032 500 mg tablets every 8 hours for 3 days
Anti-secretory synthetically manufactured small molecule designed to inhit the cystic fibrosis transmembrane conductance regulator chloride channel.
Placebo Comparator: Placebo
Oral matching placebo tablets every 8 hours for 3 days
Drug: Placebo oral tablet
Oral tablets matching iOWH032 on taste, appearance, dissolution time with the same excipients but no active ingredients.
- Diarrheal stool output rate [ Time Frame: Day 1 - Day 5 ]Diarrheal stool output rate, defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between initiation of study product dosing and initiation of antimicrobial therapy.
- Treatment emergent serious adverse events [ Time Frame: Day 1 - Day 180 ]Frequency and incidence of serious adverse events (SAEs) throughout the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150250
|Contact: Gwen Ambler, MPHemail@example.com|