A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
- Conditions
- bacterial enteritis
- Registration Number
- JPRN-jRCT2080222885
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
In this trial, OPS-2071 at 50 mg, 100 mg, and 200 mg doses was safe and well tolerated in subjects with enteric infection. OPS-2071 at 100 mg dose was safe and well tolerated in subjects with CDI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 43
The patient provides written, informed consent before the clinical trial is initiated.
-The patient has distinctive symptoms and findings of bacterial enteritis
-The patient has bacterial enteritis with one or more of the following causative pathogens either proven or presumed: Clostridium difficile (C. difficile), Salmonella,Campylobacter, pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis
-The patient and his/her partner are willing to take contraceptive measures from initiation of investigational medicinal products (IMPs) to 4 weeks after administration of IMPs.
-The patient has severe or progressive underlying disease or complication, making it difficult to ensure safety in the study or proper efficacy assessment.
-The patient has a current diagnosis or history of convulsive disorders, such as convulsion and epilepsy.
-The patient has a severe hepatic dysfunction
-The patient has a severe cardiac dysfunction
-The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. or the patient is treated with a drug reported to prolong QTc interval
-The patient has a moderate or severe renal dysfunction
-Women with confirmed or suspected pregnancy or breast-feeding women
-Patients judged to be ineligible by the investigator for any other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change of the microbiological examination
- Secondary Outcome Measures
Name Time Method efficacy<br>1. The recurrence rate of Clostridium difficile<br>infecton (CDI) after multiple doses of OPS-2071 <br>2. The time to resolution of diarrhea after multiple doses of OPS-2071 <br>3. The improvement of clinical symptoms after multiple doses of OPS-2071