At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 858 enrolled
Drug / intervention
Smecta +1 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.
Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomized, Double Blind Placebo Controlled, Parallel, Groups Study
In Brief
A Phase 4 clinical trial evaluating Smecta and Smecta placebo for Acute Diarrhoea. Completed, enrolled 858 participants across 71 sites in 6 countries.
Detailed Summary
The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Diarrhoea
CountriesAlgeria, Czechia, Egypt, Lebanon, Poland, Tunisia
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMar 2016
Primary CompletionApr 2019
TodayJul 2026
First PostedMar 9, 2016
Enrollment StartMar 17, 2016
Primary CompletionApr 8, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.3 years ago
Interventions
Smectadrug
Smecta placebodrug