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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02473393
• Date of registration: 08/06/2015
• Prospective Registration: Yes
• Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
• Public title: A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
• Date of first enrolment: August 20, 2015
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02473393
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Japan, Korea, Republic of, Singapore

Contacts

• Name: Yoshitaka Kotobuki
• Affiliation: Otsuka Pharmaceutical Co., Ltd.

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bacterial Enteritis

Intervention(s)

Drug: OPS-2071 tablet

Primary Outcome(s)

Change of the microbiological examination [Time Frame: CDI group: screening, Day 4, Day 11 (end of treatment), Enteric infection group: screening, Day 4, Day 8 (end of treatment)]

Plasma concentration of OPS-2071 on Day 4 [Time Frame: Inpatient: 1 h, 2 h, and 4 h after morning,administration , Outpatient: Once within 12 h after morning administration but before evening]

Secondary Outcome(s)

The sensitivity to OPS-2071 of the causative pathogen strain isolated from patients [Time Frame: CDI group: screening, Day 11 (end of treatment). Enteric infection group: screening, Day 8 (end of treatment)]

The recurrence rate of CDI after multiple doses of OPS-2071 [Time Frame: Day 38]

The improvement of clinical symptoms after multiple doses of OPS-2071 [Time Frame: CDI group: Day 4, Day 11 (end of treatment), and Day 38. Enteric infection group: Day 4, Day 8 (end of treatment)]

The time to resolution of diarrhea after multiple doses of OPS-2071 [Time Frame: CDI group: Day 4, Day 11 (end of treatment), and Day 38. Enteric infection group: Day 4, Day 8 (end of treatment)]

Secondary ID(s)

341-13-002

JapicCTI-152937

Source(s) of Monetary Support

Please refer to primary and secondary sponsors