Bacterial Enteritis
Conditions
Brief summary
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
Interventions
DRUGOPS-2071 tablet
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
Countries
Japan, Singapore, South Korea
Participant flow
Recruitment details
This trial was performed as a global trial in Japan, Republic of Korea, and Singapore.
Pre-assignment details
Subjects with bacterial enteritis were divided into 2 groups, a Clostridium difficile infection (CDI) group for subjects with bacterial enteritis associated with C. difficile infection and an enteric infection (EI) group for subjects with bacterial enteritis for which the causative pathogen was Salmonella, Campylobacter, or pathogenic E. coli. Only one dosage (100 mg) of OPS-2071 was administered to CDI subjects and 3 dosages (100, 50, and 200 mg) were administered to EI subjects.
Participants by arm
| Arm | Count |
|---|---|
| CDI Group OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days. | 5 |
| EI Group (50 mg) OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step. | 12 |
| EI Group (100 mg) OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step. | 12 |
| EI Group (200 mg) OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed effective, 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed not effective, 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step. | 12 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 11 Participants | 11 Participants | 12 Participants | 37 Participants |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 24.52 | 36.0 years STANDARD_DEVIATION 15.78 | 36.3 years STANDARD_DEVIATION 16.51 | 35.6 years STANDARD_DEVIATION 12.41 | 39.4 years STANDARD_DEVIATION 18.22 |
| Race/Ethnicity, Customized Japanese | 4 Participants | 12 Participants | 10 Participants | 10 Participants | 36 Participants |
| Race/Ethnicity, Customized Korean | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Others | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Singaporean | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 4 Participants | 12 Participants | 10 Participants | 12 Participants | 38 Participants |
| Region of Enrollment Singapore | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment South Korea | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 7 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants | 7 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 12 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 3 / 5 | 4 / 12 | 8 / 13 | 4 / 12 |
| serious Total, serious adverse events | 0 / 5 | 0 / 12 | 1 / 13 | 0 / 12 |
Outcome results
Primary
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)
Population: Microbiological per Protocol Set (MPPS) comprised those subjects in the FAS for whom the causative pathogen was identified and for whom microbiological outcome was assessed as Excellent, Good, or Poor , excluding subjects for whom microbiological outcome was assessed as unknown/indeterminate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDI Group | Bacterial Elimination Rate (BER) in the CDI and EI Groups | 100.0 percentage of participants |
| EI Group (50 mg) | Bacterial Elimination Rate (BER) in the CDI and EI Groups | 72.7 percentage of participants |
| EI Group (100 mg) | Bacterial Elimination Rate (BER) in the CDI and EI Groups | 90.0 percentage of participants |
| EI Group (200 mg) | Bacterial Elimination Rate (BER) in the CDI and EI Groups | 87.5 percentage of participants |
Primary
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
Population: Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CDI Group | Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | 64 µg/L |
| EI Group (50 mg) | Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | 29.2 µg/L |
| EI Group (100 mg) | Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | 42.4 µg/L |
| EI Group (200 mg) | Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | 81.9 µg/L |
Primary
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
Population: Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CDI Group | Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | 4.15 h |
| EI Group (50 mg) | Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | 1.98 h |
| EI Group (100 mg) | Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | 4.08 h |
| EI Group (200 mg) | Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | 2.42 h |
Secondary
Clinical Response Rate (CRR) in the CDI and EI Groups
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.
Time frame: CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment)
Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CDI Group | Clinical Response Rate (CRR) in the CDI and EI Groups | Day 4 | 100.0 percentage of participants |
| CDI Group | Clinical Response Rate (CRR) in the CDI and EI Groups | End of treatment | 100.0 percentage of participants |
| EI Group (50 mg) | Clinical Response Rate (CRR) in the CDI and EI Groups | End of treatment | 100.0 percentage of participants |
| EI Group (50 mg) | Clinical Response Rate (CRR) in the CDI and EI Groups | Day 4 | 100.0 percentage of participants |
| EI Group (100 mg) | Clinical Response Rate (CRR) in the CDI and EI Groups | Day 4 | 100.0 percentage of participants |
| EI Group (100 mg) | Clinical Response Rate (CRR) in the CDI and EI Groups | End of treatment | 90.0 percentage of participants |
| EI Group (200 mg) | Clinical Response Rate (CRR) in the CDI and EI Groups | Day 4 | 100.0 percentage of participants |
| EI Group (200 mg) | Clinical Response Rate (CRR) in the CDI and EI Groups | End of treatment | 100.0 percentage of participants |
Secondary
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed.
Time frame: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)
Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain at Screening | 2 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 4 | 1 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 11 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 38 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea at Screening | 1 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 4 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 11 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 38 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting at Screening | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 4 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 11 | 0 participants |
| CDI Group | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 38 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 8 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 8 | 1 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 4 | 4 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 4 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 8 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 4 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting at Screening | 2 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain at Screening | 10 participants |
| EI Group (50 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea at Screening | 6 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain at Screening | 10 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting at Screening | 3 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 4 | 3 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 8 | 0 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 4 | 0 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 8 | 0 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea at Screening | 7 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 8 | 1 participants |
| EI Group (100 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 4 | 0 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting at Screening | 0 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea at Screening | 2 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 4 | 0 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Nausea on Day 8 | 0 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 4 | 0 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain at Screening | 12 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 4 | 5 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Abdominal pain on Day 8 | 2 participants |
| EI Group (200 mg) | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Vomiting on Day 8 | 0 participants |
Secondary
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
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.
Time frame: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)
Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool at Screening | 0 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 4 | 2 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 11 | 1 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 38 | 2 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool at Screening | 4 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 4 | 0 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 11 | 2 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 38 | 0 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool at Screening | 0 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 4 | 0 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 11 | 0 participants |
| CDI Group | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 38 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 8 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 8 | 7 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 4 | 7 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 4 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 8 | 0 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 4 | 1 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool at Screening | 2 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool at Screening | 0 participants |
| EI Group (50 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool at Screening | 10 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool at Screening | 0 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool at Screening | 3 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 4 | 3 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 8 | 9 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 4 | 0 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 8 | 0 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool at Screening | 10 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 8 | 0 participants |
| EI Group (100 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 4 | 0 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool at Screening | 2 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool at Screening | 12 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 4 | 3 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Liquid or unformed stool on Day 8 | 2 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 4 | 0 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool at Screening | 0 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 4 | 5 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Formed stool on Day 8 | 8 participants |
| EI Group (200 mg) | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | Bloody stool on Day 8 | 0 participants |
Secondary
Stool Frequency Per Day After Multiple Doses of OPS-2071
Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed.
Time frame: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)
Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CDI Group | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Screening | 5.3 stool frequency/day | Standard Deviation 3.3 |
| CDI Group | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 4 | 1.5 stool frequency/day | Standard Deviation 0.58 |
| CDI Group | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 11 | 2.3 stool frequency/day | Standard Deviation 0.96 |
| CDI Group | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 38 | 1.3 stool frequency/day | Standard Deviation 0.58 |
| EI Group (50 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Screening | 7.3 stool frequency/day | Standard Deviation 2.91 |
| EI Group (50 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 4 | 2.9 stool frequency/day | Standard Deviation 1.52 |
| EI Group (50 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 8 | 2.0 stool frequency/day | Standard Deviation 1.41 |
| EI Group (100 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Screening | 7.1 stool frequency/day | Standard Deviation 2.77 |
| EI Group (100 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 4 | 1.4 stool frequency/day | Standard Deviation 0.97 |
| EI Group (100 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 8 | 1.7 stool frequency/day | Standard Deviation 0.67 |
| EI Group (200 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Screening | 9.2 stool frequency/day | Standard Deviation 4.28 |
| EI Group (200 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 4 | 2.7 stool frequency/day | Standard Deviation 2.74 |
| EI Group (200 mg) | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Day 8 | 2.6 stool frequency/day | Standard Deviation 1.93 |
Secondary
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
Population: Clinical per protocol set (CPPS) comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed. Analysis was performed by dose in the proportion of subjects judged as clinical cure at end of treatment (EOT) in the CPPS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDI Group | The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only) | 0.0 percentage of participants |
Secondary
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.
Time frame: CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment)
Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDI Group | The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 | 3.7 days | Standard Deviation 1.53 |
| EI Group (50 mg) | The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 | 4.3 days | Standard Deviation 1.34 |
| EI Group (100 mg) | The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 | 4.4 days | Standard Deviation 2.01 |
| EI Group (200 mg) | The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 | 4.6 days | Standard Deviation 1.42 |