drugset / Trial / NCT04321460
Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2020-10-01
- Primary completion
- 2021-01-04
- Completion
- 2021-01-04
Outcome
Met primary endpoint
registry analysis (superiority test); LRG-002 vs Placebo; p = 0.007; Odds Ratio (OR) 4.564 (95% CI 1.66 to 16.039); Wilcoxon (Mann-Whitney) NCT04321460 ↗
registry analysis (superiority test); LRG-002 vs Placebo; p = 0.002; Odds Ratio (OR) 4.716 (95% CI 1.898 to 14.268); Wilcoxon (Mann-Whitney) NCT04321460 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LRG-002 | Other / unclassified | 1 unknown | Oral |