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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02817347
Other study ID # YH1177-201
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2016
Est. completion date April 13, 2017

Study information

Verified date December 2021
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability, and the proportion of patients with cessation of otorrhea after ear-drop administration of YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.


Description:

Patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation. Screening should be completed within 7 days prior to randomization. patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation at randomization visit will be randomized in one of the defined groups.


Recruitment information / eligibility

Status Terminated
Enrollment 135
Est. completion date April 13, 2017
Est. primary completion date April 13, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Signed Written Informed Consent A detailed explanation about the study, including the study purpose and procedures and drug properties, had been provided, and the patient gave voluntary written informed consent. - Target Population Patients with otitis media presenting with otorrhea, as evidenced by otoscopy, who had tympanostomy tube insertion or tympanic perforation - Sex and age Male or female patients 19 years of age or older at screening Women of childbearing potential (WOCBP) must have 'negative' pregnancy test at screening, and use an acceptable method of contraception throughout the study. Exclusion Criteria: - Excluded Disease 1. Patients diagnosed with otitis media with cholesteatoma, otitis media with effusion or otitis externa at screening 2. Patients who had a otologic surgery within 1 year prior to screening (except for tympanostomy tube insertion) 3. Subjects who previously had cholesteatoma or mastoid surgery - Medical History and Concurrent Disease 1. Patients with complication of labyrinthine fistula at screening 2. Patients with clinically significant medical or mental illness. 3. Patients with infectious disease requiring the use of systemic antimicrobial therapy - Physical and Laboratory Test Results a)Clinically significant finding based on the principal investigator/investigator's opinion. - Allergies and Adverse Drug Reactions 1. Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity) 2. History of hypersensitivity to penicillins or -lactamase inhibitors. 3. History of serious skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrosis - Prohibited Therapies and/or Medication 1. Patients undergoing a ventilation tube insertion on the day of screening 2. Patients with ventilation tube containing silver oxide or silver salt (e.g., T-type tube) - Reproductive status, Women only a)Woman of childbearing potential (WOCBP) who is unable, or unwilling to use an acceptable method of contraception during the study - Other Exclusion Criteria 1. History of alcohol or drug abuse/addiction within the last 1 year prior to the study entry 2. Patient who, in the investigator's opinion, is not suitable for the study for any reason (e.g., ECG or hepatitis test results at screening)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

piperacillin 2% + tazobactam 0.25%

piperacillin 4% + tazobactam 0.5%

piperacillin 8% + tazobactam 1.0%


Locations

Country Name City State
Korea, Republic of Chonnam National Universitiy Hospital Gwangju Chonnam

Sponsors (1)

Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Cmax Maximum plasma concentration pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Other AUClast The area under the plasma concentration-time curve from time zero until the last measurable concentration pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Other AUCinf The area under the plasma concentration - time curve from time zero to infinite time pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Other Tmax Time to reach Cmax pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Other t1/2 Terminal elimination half-life pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Other CL/F Apparent plasma clearance pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Other Vd/F Apparent volume of distribution pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Primary The proportion of patients achieving cessation of otorrhea on Day 15. The proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy Day 15
Secondary The proportion of patients with cessation of otorrhea on Day 8. The proportion of patients with cessation of otorrhea on Day 8 as evidenced by otoscopy. Day 8
Secondary The proportion of patients with cessation of otorrhea on Day 22. The proportion of patients with cessation of otorrhea on Day 22 as evidenced by otoscopy. Day 22
Secondary Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy 'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale Day 8
Secondary Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy 'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale Day 15
Secondary Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy 'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale Day 22
Secondary Microbiological eradication Proportion of patients with microbiological eradicationat each visit Day 8, 15, 22
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