Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04321460
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2020-03-24
Brief Title:
Study of LRG-002 Hard Capsules Lek dd Slovenia Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults
Sponsor:
Sandoz
Organization:
Sandoz
Study Overview
Official Title:
Multicentre Double-blind Randomized Placebo-controlled Parallel-group Efficacy and Safety Study of LRG-002 Hard Capsules Lek dd Slovenia Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study was to investigate the efficacy and safety of LRG-002 investigational medicinal product capsules Lek dd 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
Detailed Description:
This study was the prospective multi-centered double-blinded randomized parallel-group clinical study The study investigated the efficacy and safety of LRG-002 investigational medicinal product capsules Lek dd 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
The study comprised the following periods
Study Periods Visit 1 Day 1 Screening randomization initiation of treatment
Patients started participating in the study after signing the Informed Consent Form Having completed screening tests eligible patients were randomized on the same day to receive either LRG-002 or matching placebo capsules each as an adjunct to the prescribed antibiotic The treatment group was determined by randomization at a center ratio Study subjects were supplied with the patient diary and blinded investigational product investigational medicinal product or placebo depending on the assigned treatment group Patients could start study treatment only after receiving appropriate training On Day 1 the study started in both groups from randomization and administration of the first dose of the investigational product depending on the assigned group after randomization
Group T treated with LRG-002 a single dose of 1 oral hard capsule taken during meals with some water the product was to be taken orally 2 times per day for 14 days
Group R provided with placeboa single dose of 1 oral hard capsule taken during meals with some water the product is to be taken orally 2 times per day for 14 days
Visit 2 Day 7 Intermediate Follow-up Visit
Visit 3 Day 15 Visit 3 was scheduled at Day 15 when a patient was to come to the study site bringing along the completed diary unused laboratory kit unused product and empty packages
The study comprised the following periods
Study Periods Visit 1 Day 1 Screening randomization initiation of treatment
Patients started participating in the study after signing the Informed Consent Form Having completed screening tests eligible patients were randomized on the same day to receive either LRG-002 or matching placebo capsules each as an adjunct to the prescribed antibiotic The treatment group was determined by randomization at a center ratio Study subjects were supplied with the patient diary and blinded investigational product investigational medicinal product or placebo depending on the assigned treatment group Patients could start study treatment only after receiving appropriate training On Day 1 the study started in both groups from randomization and administration of the first dose of the investigational product depending on the assigned group after randomization
Group T treated with LRG-002 a single dose of 1 oral hard capsule taken during meals with some water the product was to be taken orally 2 times per day for 14 days
Group R provided with placeboa single dose of 1 oral hard capsule taken during meals with some water the product is to be taken orally 2 times per day for 14 days
Visit 2 Day 7 Intermediate Follow-up Visit
Visit 3 Day 15 Visit 3 was scheduled at Day 15 when a patient was to come to the study site bringing along the completed diary unused laboratory kit unused product and empty packages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None