Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LRG-002 · 1 trial · 1 indication
Diarrhea is defined as loose or watery stool (Type 5-7 according to Bristol Stool Form Scale (BSFS)), three times a day (frequent bowel movements with formed stool is not considered as diarrhea) in accordance with WHO criteria; based on the diary data (BSFS) and confirmation of AAD by the investigator. BSFS scale includes Types 1 to 7 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhea. AAD (antibiotic-associated diarrhea) is defined as diarrhea associated with the antibiotic use caused by C. difficile or of otherwise not identified etiology, upon analysis of stool samples and differential diagnostics according to investigator's judgment. Diarrhea was assessed in a diary.
Diarrhea is defined as loose or watery stool (Type 5-7 according to Bristol Stool Form Scale (BSFS)), three times a day (frequent bowel movements with formed stool is not considered as diarrhea) in accordance with WHO criteria; based on the diary data (BSFS) and confirmation of AAD by the investigator. BSFS scale includes Types 1 to 7 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhea. AAD (antibiotic-associated diarrhea) is defined as diarrhea associated with the antibiotic use caused by C. difficile or of otherwise not identified etiology, upon analysis of stool samples and differential diagnostics according to investigator's judgment. Diarrhea was assessed in a diary.
| Arm | Type | Description |
|---|---|---|
| LRG-002 | EXPERIMENTAL | LRG-002 once daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| LRG-002 | DRUG | Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus |
| Placebo | DRUG | Capsules containing placebo |
Patients will be considered eligible for study participation if they meet the following inclusion criteria: 1. An Informed Consent Form for study participation voluntarily signed by a patient; 2. Male and female subjects, 18 to 65 years of age inclusive; 3. Antibacterial treatment for active ARDs s...
LRG-002 is an investigational small molecule being developed for the prophylaxis of antibiotic-associated diarrhea in adults. It is intended to prevent diarrhea that occurs as a complication of antibiotic use. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
LRG-002 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is in Phase 3 clinical development for the prophylaxis of antibiotic-associated diarrhea in adults.
LRG-002 is in Phase 3 clinical development. It is an investigational drug being studied for the prophylaxis of antibiotic-associated diarrhea in adults. The drug has not been approved by regulatory authorities and remains in clinical trials to evaluate its safety and efficacy.
LRG-002 has one completed Phase 3 clinical trial, identified as NCT04321460. This randomized, double-blind, placebo-controlled study enrolled 520 adults in Russia to evaluate the drug for the prophylaxis of antibiotic-associated diarrhea. The trial has been completed, and no active trials are currently listed.
No alternative names for LRG-002 have been identified. The drug is referred to by its code name LRG-002 in clinical development. It is being studied by Novartis AG for the prophylaxis of antibiotic-associated diarrhea in adults.