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A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea

Primary Purpose

Otitis Media, Otorrhea

Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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%
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chonnam National Universitiy Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

YH1177 (4/0.5%+0.1%)

YH1177 (8/1.0%+0.1%)

YH1177-D (2/0.25%)

YH1177-D (4/0.5%)

YH1177-D (8/1.0%)

Arm Description

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%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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
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
Microbiological eradication
Proportion of patients with microbiological eradicationat each visit

Full Information

First Posted
June 13, 2016
Last Updated
December 26, 2021
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02817347
Brief Title
A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea
Official Title
A Randomized, Double-blind, Multicenter, Phase2 Trial to Evaluate the Safety and Efficacy of YH1177 or YH1177-D Otic Soultion in Patients With Otitis Media and Otorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision for the Drug Development.
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 13, 2017 (Actual)
Study Completion Date
April 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Otorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YH1177 (4/0.5%+0.1%)
Arm Type
Experimental
Arm Description
piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%
Arm Title
YH1177 (8/1.0%+0.1%)
Arm Type
Experimental
Arm Description
piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%
Arm Title
YH1177-D (2/0.25%)
Arm Type
Experimental
Arm Description
piperacillin 2% + tazobactam 0.25%
Arm Title
YH1177-D (4/0.5%)
Arm Type
Experimental
Arm Description
piperacillin 4% + tazobactam 0.5%
Arm Title
YH1177-D (8/1.0%)
Arm Type
Experimental
Arm Description
piperacillin 8% + tazobactam 1.0%
Intervention Type
Drug
Intervention Name(s)
piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%
Other Intervention Name(s)
YH1177 (4/0.5%+0.1%)
Intervention Type
Drug
Intervention Name(s)
piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%
Other Intervention Name(s)
YH1177 (8/1.0%+0.1%)
Intervention Type
Drug
Intervention Name(s)
piperacillin 2% + tazobactam 0.25%
Other Intervention Name(s)
YH1177-D (2/0.25%)
Intervention Type
Drug
Intervention Name(s)
piperacillin 4% + tazobactam 0.5%
Other Intervention Name(s)
YH1177-D (4/0.5%)
Intervention Type
Drug
Intervention Name(s)
piperacillin 8% + tazobactam 1.0%
Other Intervention Name(s)
YH1177-D (8/1.0 %)
Primary Outcome Measure Information:
Title
The proportion of patients achieving cessation of otorrhea on Day 15.
Description
The proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
The proportion of patients with cessation of otorrhea on Day 8.
Description
The proportion of patients with cessation of otorrhea on Day 8 as evidenced by otoscopy.
Time Frame
Day 8
Title
The proportion of patients with cessation of otorrhea on Day 22.
Description
The proportion of patients with cessation of otorrhea on Day 22 as evidenced by otoscopy.
Time Frame
Day 22
Title
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
Description
'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
Time Frame
Day 8
Title
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
Description
'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
Time Frame
Day 15
Title
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
Description
'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
Time Frame
Day 22
Title
Microbiological eradication
Description
Proportion of patients with microbiological eradicationat each visit
Time Frame
Day 8, 15, 22
Other Pre-specified Outcome Measures:
Title
Cmax
Description
Maximum plasma concentration
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Title
AUClast
Description
The area under the plasma concentration-time curve from time zero until the last measurable concentration
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Title
AUCinf
Description
The area under the plasma concentration - time curve from time zero to infinite time
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Title
Tmax
Description
Time to reach Cmax
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Title
t1/2
Description
Terminal elimination half-life
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Title
CL/F
Description
Apparent plasma clearance
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours
Title
Vd/F
Description
Apparent volume of distribution
Time Frame
pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Patients diagnosed with otitis media with cholesteatoma, otitis media with effusion or otitis externa at screening Patients who had a otologic surgery within 1 year prior to screening (except for tympanostomy tube insertion) Subjects who previously had cholesteatoma or mastoid surgery Medical History and Concurrent Disease Patients with complication of labyrinthine fistula at screening Patients with clinically significant medical or mental illness. 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 Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity) History of hypersensitivity to penicillins or -lactamase inhibitors. History of serious skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrosis Prohibited Therapies and/or Medication Patients undergoing a ventilation tube insertion on the day of screening 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 History of alcohol or drug abuse/addiction within the last 1 year prior to the study entry 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chulho jang, M.D Ph.D
Organizational Affiliation
Chonnam National Universitiy Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chonnam National Universitiy Hospital
City
Gwangju
State/Province
Chonnam
ZIP/Postal Code
501-757
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea

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