Clinical trial NCT02473393: A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Enteritis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Bacterial Elimination Rate (BER) in the CDI and EI Groups
timeFrame: CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment)
measure: Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4
timeFrame: Inpatient: 1h, 2h, and 4h after morning administration
measure: Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4
timeFrame: 1h, 2h, and 4h after morning administration
Secondary outcomes:
measure: The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)
timeFrame: Day 38
measure: The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071
timeFrame: CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment)
measure: Stool Frequency Per Day After Multiple Doses of OPS-2071
timeFrame: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)
measure: Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
timeFrame: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)
measure: Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
timeFrame: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)
measure: Clinical Response Rate (CRR) in the CDI and EI Groups
timeFrame: CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment)
Other outcomes:
Locations:
city: Kanto, Region
country: Japan
city: Seoul
country: Korea, Republic of
city: Singapore
country: Singapore
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yoshitaka Kotobuki
role: STUDY_DIRECTOR
References: