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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Bacterial Enteritis

Treatments: Drug: OPS-2071 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02473393

JapicCTI-152937 (Other Identifier)

341-13-002

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 4 patient groups

OPS-2071 50mg/day

Experimental group

Description:

OPS-2071 50 mg/day：25 mg tablet administered orally twice daily

Treatment:

Drug: OPS-2071 tablet

OPS-2071 100 mg/day

Experimental group

Description:

OPS-2071 100 mg/day：50 mg tablet administered orally twice daily

Treatment:

Drug: OPS-2071 tablet

OPS-2071 200 mg/day

Experimental group

Description:

OPS-2071 200 mg/day：100 mg tablet administered orally twice daily

Treatment:

Drug: OPS-2071 tablet

OPS-2071 400 mg/day

Experimental group

Description:

OPS-2071 400 mg/day：100 mg two tablets administered orally twice daily

Treatment:

Drug: OPS-2071 tablet