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

An open-label, multicenter clinical trial to assess the safety and efficacy of three different doses of OPS-2071 in patients with bacterial enteritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222885

Enrollment

Registered

2015-06-17

Start date

2015-08-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bacterial enteritis

Interventions

investigational material(s) Generic name etc : OPS-2071 INN of investigational material : - Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion 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: 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy Change of the microbiological examination	—

Secondary

Measure	Time frame
efficacy 1. The recurrence rate of Clostridium difficile infecton (CDI) after multiple doses of OPS-2071 2. The time to resolution of diarrhea after multiple doses of OPS-2071 3. The improvement of clinical symptoms after multiple doses of OPS-2071	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026