Phase 2
Completed N=43
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Bacterial Enteritis
Source: ClinicalTrials.gov NCT02473393 ↗
Enrolled (actual)
43
Serious AEs
2.4%
Results posted
Mar 2021
Primary outcomePrimary: Bacterial Elimination Rate (BER) in the CDI and EI Groups — 100.0; 72.7; 90.0; 87.5 percentage of participants
Summary
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Elimination Rate (BER) in the CDI and EI Groups |
100.0; 72.7; 90.0; 87.5 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 |
64; 29.2; 42.4; 81.9 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 |
4.15; 1.98; 4.08; 2.42 | — |
| SECONDARY The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only) |
0.0 | — |
| SECONDARY The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 |
3.7; 4.3; 4.4; 4.6 | — |
| SECONDARY Stool Frequency Per Day After Multiple Doses of OPS-2071 |
5.3; 7.3; 7.1; 9.2; 1.5; 2.9 | — |
| SECONDARY Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 |
0; 0; 0; 0; 2; 7 | — |
| SECONDARY Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 |
2; 10; 10; 12; 1; 4 | — |
| SECONDARY Clinical Response Rate (CRR) in the CDI and EI Groups |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02473393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.