At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 520 enrolled
Drug / intervention
LRG-002 +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.
Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Efficacy and Safety Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
In Brief
A Phase 3 clinical trial evaluating LRG-002 and Placebo for Antibiotic-associated Diarrhea. Completed, enrolled 520 participants across 3 sites.
Detailed Summary
The goal of this study was to investigate the efficacy and safety of LRG-002 investigational medicinal product, capsules (Lek d.d., Slovenia) in comparison with placebo, as an adjunct treatment for prophylaxis of antibiotic-associated diarrhea (AAD) in patients with acute respiratory diseases (ARDs) receiving a standard antimicrobial therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAntibiotic-associated Diarrhea
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartOct 2020
Primary CompletionJan 2021
TodayJul 2026
First PostedMar 25, 2020
Enrollment StartOct 1, 2020
Primary CompletionJan 4, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.3 years ago
Interventions
LRG-002drug
Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus
Placebodrug
Capsules containing placebo