Phase 2 N=43 Randomized Treatment

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

Bacterial Enteritis

Bottom Line

View on ClinicalTrials.gov: NCT02473393 ↗

Enrolled (actual)

Serious AEs

2.4%

Results posted

Mar 2021

Primary outcome: Primary: Bacterial Elimination Rate (BER) in the CDI and EI Groups — 100.0; 72.7; 90.0; 87.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OPS-2071 tablet (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Bacterial Elimination Rate (BER) in the CDI and EI Groups	100.0; 72.7; 90.0; 87.5	—
PRIMARY Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4	64; 29.2; 42.4; 81.9	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4	4.15; 1.98; 4.08; 2.42	—
SECONDARY The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)	0.0	—
SECONDARY The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071	3.7; 4.3; 4.4; 4.6	—
SECONDARY Stool Frequency Per Day After Multiple Doses of OPS-2071	5.3; 7.3; 7.1; 9.2; 1.5; 2.9	—
SECONDARY Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071	0; 0; 0; 0; 2; 7	—
SECONDARY Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071	2; 10; 10; 12; 1; 4	—
SECONDARY Clinical Response Rate (CRR) in the CDI and EI Groups	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02473393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.