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

Otsuka Pharmaceutical Co., Ltd.43 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Enteritis

Interventions

OPS-2071 tabletDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Kanto, Region, Japan

Unnamed facility

Singapore, Singapore

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Bacterial Elimination Rate (BER) in the CDI and EI Groups

Judged according to the assessment criteria for the bacterial strain isolated as the causative pathogen based on the data from the microbiological examination. Analysis was performed by disease group and by dose, and by minimum inhibitory concentration (MIC) values of OPS-2071 for each of the causative strains (Enterotoxigenic E. coli, Enteroaggregative E. coli, Campylobacter sp., C. jejuni, S. aureus, K. oxytoca, and C. perfringens for the EI group). Data were shown as all strains total. Concerning microbiological outcome by causative strain, bacteria elimination rate (BER) and its 95% confidence interval (CI) were calculated. The BER was the proportion of causative strains assessed as either "Excellent" or "Good" except for those assessed as "unknown/indeterminate".

Time frame: CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment)

Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4

We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma.

Time frame: Inpatient: 1h, 2h, and 4h after morning administration

Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4

We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma.

Time frame: 1h, 2h, and 4h after morning administration

Secondary Outcomes

The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)

CDI recurrence rate at follow-up (Day 38) or withdrawal was calculated. CDI recurrence rate was the proportion of the subjects judged as "recurrent" against evaluable subjects, except for those with missing data.

Time frame: Day 38

The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071

The time from the start of dosing until the first formed stool (except in cases where liquid or unformed stools recurred) was evaluated as time to resolution of diarrhea. If formed stool has not been observed, then the subject will be handled as missing data.

Data from ClinicalTrials.gov

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