A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis

• Status: Completed
• Trial end date: 2017-03-14
• Target enrollment: 0
• Participant gender: All

Summary

To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 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: 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

Exclusion Criteria:

• 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