A Phase 2 interventional study of OPS-2071 tablet in Bacterial Enteritis, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 3 sites in 3 countries. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-03-24.
Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
34 studies on the registry are indexed under Enteritis; 7 are open to participants now.
This study's enrollment of 43 is below the median of 53 across 26 interventional studies indexed under Enteritis.
Browse Enteritis studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
OPS-2071 50 mg/day：25 mg tablet administered orally twice daily
Drug: OPS-2071 tablet
OPS-2071 100 mg/day：50 mg tablet administered orally twice daily
Drug: OPS-2071 tablet
OPS-2071 200 mg/day：100 mg tablet administered orally twice daily
Drug: OPS-2071 tablet
OPS-2071 400 mg/day：100 mg two tablets administered orally twice daily
Drug: OPS-2071 tablet
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)
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
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
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
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)
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)
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)
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)
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)
This trial was performed as a global trial in Japan, Republic of Korea, and Singapore.
| Milestone | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Started | 5 | 12 | 13 | 13 |
| Completed | 5 | 12 | 11 | 12 |
| Not completed | 0 | 0 | 2 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 |
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".
| percentage of participants | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Bacterial Elimination Rate (BER) in the CDI and EI Groups | 100.0 (15.8 to 100.0) | 72.7 (39.0 to 94.0) | 90.0 (55.5 to 99.7) | 87.5 (47.3 to 99.7) |
We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma.
| µg/L | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | 64 | 29.2 (17.7 to 40.6) | 42.4 (38.5 to 46.2) | 81.9 (62.8 to 101) |
We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma.
| h | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | 4.15 (4.15 to 4.15) | 1.98 (1.95 to 2.00) | 4.08 (4.03 to 4.12) | 2.42 (0.92 to 3.92) |
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.
| percentage of participants | CDI Group |
|---|---|
| The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only) | 0.0 |
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.
| days | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 | 3.7 ± 1.53 | 4.3 ± 1.34 | 4.4 ± 2.01 | 4.6 ± 1.42 |
Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed.
| stool frequency/day | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Screening | 5.3 ± 3.30 | 7.3 ± 2.91 | 7.1 ± 2.77 | 9.2 ± 4.28 |
| Day 4 | 1.5 ± 0.58 | 2.9 ± 1.52 | 1.4 ± 0.97 | 2.7 ± 2.74 |
| Day 8 | — | 2.0 ± 1.41 | 1.7 ± 0.67 | 2.6 ± 1.93 |
| Day 11 | 2.3 ± 0.96 | — | — | — |
| Day 38 | 1.3 ± 0.58 | — | — | — |
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.
| participants | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Formed stool at Screening | 0 | 0 | 0 | 0 |
| Formed stool on Day 4 | 2 | 7 | 3 | 5 |
| Formed stool on Day 8 | — | 7 | 9 | 8 |
| Formed stool on Day 11 | 1 | — | — | — |
| Formed stool on Day 38 | 2 | — | — | — |
| Liquid or unformed stool at Screening | 4 | 10 | 10 | 12 |
| Liquid or unformed stool on Day 4 | 0 | 1 | 0 | 3 |
| Liquid or unformed stool on Day 8 | — | 0 | 0 | 2 |
| Liquid or unformed stool on Day 11 | 2 | — | — | — |
| Liquid or unformed stool on Day 38 | 0 | — | — | — |
| Bloody stool at Screening | 0 | 2 | 3 | 2 |
| Bloody stool on Day 4 | 0 | 0 | 0 | 0 |
| Bloody stool on Day 8 | — | 0 | 0 | 0 |
| Bloody stool on Day 11 | 0 | — | — | — |
| Bloody stool on Day 38 | 0 | — | — | — |
Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed.
| participants | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Abdominal pain at Screening | 2 | 10 | 10 | 12 |
| Abdominal pain on Day 4 | 1 | 4 | 3 | 5 |
| Abdominal pain on Day 8 | — | 1 | 0 | 2 |
| Abdominal pain on Day 11 | 0 | — | — | — |
| Abdominal pain on Day 38 | 0 | — | — | — |
| Nausea at Screening | 1 | 6 | 7 | 2 |
| Nausea on Day 4 | 0 | 0 | 0 | 0 |
| Nausea on Day 8 | — | 0 | 0 | 0 |
| Nausea on Day 11 | 0 | — | — | — |
| Nausea on Day 38 | 0 | — | — | — |
| Vomiting at Screening | 0 | 2 | 3 | 0 |
| Vomiting on Day 4 | 0 | 0 | 0 | 0 |
| Vomiting on Day 8 | — | 0 | 1 | 0 |
| Vomiting on Day 11 | 0 | — | — | — |
| Vomiting on Day 38 | 0 | — | — | — |
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.
| percentage of participants | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| Day 4 | 100.0 (39.8 to 100.0) | 100.0 (69.2 to 100.0) | 100.0 (69.2 to 100.0) | 100.0 (73.5 to 100.0) |
| End of treatment | 100.0 (39.8 to 100.0) | 100.0 (69.2 to 100.0) | 90.0 (55.5 to 99.7) | 100.0 (73.5 to 100.0) |
Collected over From the start day of IMP administration up to Day 38. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CDI Group | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| EI Group (50 mg) | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| EI Group (100 mg) | 0/13 (0%) | 1/13 (7.7%) | 8/13 (61.5%) |
| EI Group (200 mg) | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Event | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| PyrexiaGeneral disorders | 0/5 | 0/12 | 1/13 | 0/12 |
| Event | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/5 | 0/12 | 0/13 | 0/12 |
| Cardiac failureCardiac disorders | 1/5 | 0/12 | 0/13 | 0/12 |
| DiarrhoeaGastrointestinal disorders | 1/5 | 0/12 | 0/13 | 0/12 |
| PneumoniaInfections and infestations | 1/5 | 0/12 | 0/13 | 0/12 |
| Urinary tract infectionInfections and infestations | 1/5 | 0/12 | 0/13 | 0/12 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/5 | 0/12 | 0/13 | 0/12 |
| HypokalaemiaMetabolism and nutrition disorders | 1/5 | 0/12 | 0/13 | 0/12 |
| Chondrocalcinosis pyrophosphateMusculoskeletal and connective tissue disorders | 1/5 | 0/12 | 0/13 | 0/12 |
| Alanine aminotransferase increasedInvestigations | 0/5 | 2/12 | 0/13 | 1/12 |
| HeadacheNervous system disorders | 0/5 | 1/12 | 2/13 | 0/12 |
Full Analysis Set (FAS): all subjects who had received the investigational medicinal product (IMP) at least once and from whom data on at least one efficacy endpoint had been obtained after the start of IMP administration.
| Age, Categorical(Participants) | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 11 | 11 | 12 | 37 |
| >=65 years | 2 | 1 | 1 | 0 | 4 |
| Age, Continuous(years) | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) | Total |
|---|---|---|---|---|---|
| Mean | 64.0 ± 24.52 | 36.0 ± 15.78 | 36.3 ± 16.51 | 35.6 ± 12.41 | 39.4 ± 18.22 |
| Sex: Female, Male(Participants) | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) | Total |
|---|---|---|---|---|---|
| Female | 3 | 5 | 7 | 5 | 20 |
| Male | 2 | 7 | 5 | 7 | 21 |
| Race/Ethnicity, Customized(Participants) | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) | Total |
|---|---|---|---|---|---|
| Japanese | 4 | 12 | 10 | 10 | 36 |
| Korean | 0 | 0 | 2 | 1 | 3 |
| Singaporean | 0 | 0 | 0 | 0 | 0 |
| Others | 1 | 0 | 0 | 1 | 2 |
| Region of Enrollment(Participants) | CDI Group | EI Group (50 mg) | EI Group (100 mg) | EI Group (200 mg) | Total |
|---|---|---|---|---|---|
| South Korea | 0 | 0 | 2 | 0 | 2 |
| Singapore | 1 | 0 | 0 | 0 | 1 |
| Japan | 4 | 12 | 10 | 12 | 38 |
PDFs hosted by the registry, ClinicalTrials.gov.
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