Bacterial EnteritisPhase 2NCT02473393

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

A Phase 2 study testing OPS-2071 tablet in people with Bacterial Enteritis, run by Otsuka Pharmaceutical Co., Ltd. at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 19 to 74 years
Conditions the study is for: Bacterial Enteritis
What is being tested?: OPS-2071 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 3 sitesin 3 countries
Study dates: 20 Aug 2015to 14 Mar 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Japan1 site

Study site
Kanto, Region

Other trials in Japan

Singapore1 site

Study site
Singapore

Other trials in Singapore

South Korea1 site

Study site
Seoul

Other trials in South Korea

About this study

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

Conditions: Bacterial Enteritis
Being tested: OPS-2071 tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPS-2071 tabletDrug

Study groups in NCT02473393
Study group	Role	What they receive
OPS-2071 50mg/day	Experimental	OPS-2071 50 mg/day：25 mg tablet administered orally twice daily Receives: Drug: OPS-2071 tablet
OPS-2071 100 mg/day	Experimental	OPS-2071 100 mg/day：50 mg tablet administered orally twice daily Receives: Drug: OPS-2071 tablet
OPS-2071 200 mg/day	Experimental	OPS-2071 200 mg/day：100 mg tablet administered orally twice daily Receives: Drug: OPS-2071 tablet
OPS-2071 400 mg/day	Experimental	OPS-2071 400 mg/day：100 mg two tablets administered orally twice daily Receives: Drug: OPS-2071 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 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.
Measured: 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.
Measured: 1h, 2h, and 4h after morning administration

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 201514 Mar 2017

First posted16 Jun 2015 (estimated)
Study start20 Aug 2015
Primary completion14 Mar 2017
Study completion14 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bacterial EnteritisStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02473393
Sponsor's protocol ID: 341-13-002
Other IDs: JapicCTI-152937
Status last verified: Mar 2021
First submitted: 8 Jun 2015
Last updated: 24 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
FMT in Initial CDI
Clostridioides Difficile Infection
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Recruiting
Safety and Efficacy of Fecal Microbiota Transplantation
Crohn Disease, Ulcerative Colitis

All Bacterial Enteritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
ClinicalTrials.gov ID: NCT02473393
Acronym / sponsor ID: 341-13-002
Conditions: Bacterial Enteritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Aug 2015 (actual)
Primary completion: 14 Mar 2017 (actual)
Study completion: 14 Mar 2017 (actual)
First posted: 16 Jun 2015 (estimated)
Results: Posted 24 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
OPS-2071 50mg/day	Experimental	Drug: OPS-2071 tabletOPS-2071 50 mg/day：25 mg tablet administered orally twice daily
OPS-2071 100 mg/day	Experimental	Drug: OPS-2071 tabletOPS-2071 100 mg/day：50 mg tablet administered orally twice daily
OPS-2071 200 mg/day	Experimental	Drug: OPS-2071 tabletOPS-2071 200 mg/day：100 mg tablet administered orally twice daily
OPS-2071 400 mg/day	Experimental	Drug: OPS-2071 tabletOPS-2071 400 mg/day：100 mg two tablets administered orally twice daily

Who may qualify

Ages: 19 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPS-2071 tablet	Drug	OPS-2071 100 mg/day, OPS-2071 200 mg/day, OPS-2071 400 mg/day, OPS-2071 50mg/day

Primary outcome

Bacterial Elimination Rate (BER) in the CDI and EI Groups
Time frame: 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
Time frame: 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
Time frame: 1h, 2h, and 4h after morning administration
We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma.

6 secondary outcomes

The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)
Time frame: Day 38
The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071
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
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
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
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
Time frame: CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment)

Results and safety

Results posted to the registry on 24 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CDI Group	5	5
EI Group (50 mg)	12	12
EI Group (100 mg)	13	11
EI Group (200 mg)	13	12

Primary outcome: Bacterial Elimination Rate (BER) in the CDI and EI Groups

Time frame: CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment). Number (95% Confidence Interval). Unit: percentage of participants

Measure	CDI Group n = 2	EI Group (50 mg) n = 9	EI Group (100 mg) n = 9	EI Group (200 mg) n = 7
Value	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)

Population analysed: 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".

Primary outcome: Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4

Time frame: Inpatient: 1h, 2h, and 4h after morning administration. Mean (Full Range). Unit: µg/L

Measure	CDI Group n = 1	EI Group (50 mg) n = 2	EI Group (100 mg) n = 2	EI Group (200 mg) n = 2
Value	64	29.2 (17.7 to 40.6)	42.4 (38.5 to 46.2)	81.9 (62.8 to 101)

Population analysed: Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once.

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4

Time frame: 1h, 2h, and 4h after morning administration. Mean (Full Range). Unit: h

Measure	CDI Group n = 1	EI Group (50 mg) n = 2	EI Group (100 mg) n = 2	EI Group (200 mg) n = 2
Value	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)

Population analysed: Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start day of IMP administration up to Day 38. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CDI Group	0 of 5 (0%)	3 of 5 (60%)	0 of 5
EI Group (50 mg)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
EI Group (100 mg)	1 of 13 (7.7%)	8 of 13 (61.5%)	0 of 13
EI Group (200 mg)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bacterial Enteritis

Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
FMT in Initial CDI
Clostridioides Difficile Infection
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Recruiting
Safety and Efficacy of Fecal Microbiota Transplantation
Crohn Disease, Ulcerative Colitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoshitaka Kotobuki study director

Otsuka Pharmaceutical Co., Ltd.

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPS-2071 tablet in people with Bacterial Enteritis, run by Otsuka Pharmaceutical Co., Ltd. at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan, Singapore, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacterial Elimination Rate (BER) in the CDI and EI Groups (time frame: CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.