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Completed

NCT Number: NCT02473393

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

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

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Key information

Conditions

Bacterial Enteritis

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kanto, Region, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPS-2071 tablet

Drug

Primary outcomes

  1. 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".

  2. 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.

  3. 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.

Secondary outcomes

  1. The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)

    Time frame: 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.

  2. 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)

    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.

  3. 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)

    Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed.

  4. 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)

    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.

  5. 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)

    Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed.

  6. 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)

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2015
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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