A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
- Conditions
- Bacterial Enteritis
- Interventions
- Drug: OPS-2071 tablet
- Registration Number
- NCT02473393
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPS-2071 50mg/day OPS-2071 tablet OPS-2071 50 mg/day：25 mg tablet administered orally twice daily OPS-2071 200 mg/day OPS-2071 tablet OPS-2071 200 mg/day：100 mg tablet administered orally twice daily OPS-2071 100 mg/day OPS-2071 tablet OPS-2071 100 mg/day：50 mg tablet administered orally twice daily OPS-2071 400 mg/day OPS-2071 tablet OPS-2071 400 mg/day：100 mg two tablets administered orally twice daily
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 Inpatient: 1h, 2h, and 4h after morning administration We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma.
Bacterial Elimination Rate (BER) in the CDI and EI Groups CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment) 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 to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 1h, 2h, and 4h after morning administration We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) Under each disease group, the improvement of clinical symptoms ((i.e. formed stool, liquid or unformed stool \[3 and more times\], and presence of bloody stool) were assessed.
Clinical Response Rate (CRR) in the CDI and EI Groups CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment) The CRR and 95% CI at each evaluation time point were calculated. The CRR was calculated as the proportion of the subjects judged as "clinical cure" or "clinical improvement" against evaluable subjects, except for those with missing data.
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed.
The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only) Day 38 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.
The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment) 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.
Stool Frequency Per Day After Multiple Doses of OPS-2071 CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed.