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TerminatedNCT02817347Updated Jan 13, 2022

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

A Phase 1/2 interventional study of piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1% and piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1% in Otitis Media and Otorrhea, sponsored by Yuhan Corporation. Terminated at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Yuhan Corporation · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Sponsor's decision for the Drug Development.
Phase
Phase 1/2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Otitis Media
  • Otorrhea

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03

In context

Otitis Media

288 studies on the registry are indexed under Otitis Media; 35 are open to participants now.

This study's enrollment of 135 is close to the median of 135 across 197 interventional studies indexed under Otitis Media.

Browse Otitis Media studies →

Lead sponsor

Yuhan Corporation is the lead sponsor of 108 studies on the registry; 6 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    YH1177 (4/0.5%+0.1%)

    piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

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

  • Experimental
    YH1177 (8/1.0%+0.1%)

    piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

    Drug: piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

  • Experimental
    YH1177-D (2/0.25%)

    piperacillin 2% + tazobactam 0.25%

    Drug: piperacillin 2% + tazobactam 0.25%

  • Experimental
    YH1177-D (4/0.5%)

    piperacillin 4% + tazobactam 0.5%

    Drug: piperacillin 4% + tazobactam 0.5%

  • Experimental
    YH1177-D (8/1.0%)

    piperacillin 8% + tazobactam 1.0%

    Drug: piperacillin 8% + tazobactam 1.0%

Interventions

  • Drugpiperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

    Drug page: Piperacillin

    Also known as: YH1177 (4/0.5%+0.1%)

  • Drugpiperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

    Drug page: Piperacillin

    Also known as: YH1177 (8/1.0%+0.1%)

  • Drugpiperacillin 2% + tazobactam 0.25%

    Drug page: Piperacillin

    Also known as: YH1177-D (2/0.25%)

  • Drugpiperacillin 4% + tazobactam 0.5%

    Drug page: Piperacillin

    Also known as: YH1177-D (4/0.5%)

  • Drugpiperacillin 8% + tazobactam 1.0%

    Drug page: Piperacillin

    Also known as: YH1177-D (8/1.0 %)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 15

Secondary outcomes

  1. 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.

    Time frame: Day 8

  2. 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.

    Time frame: Day 22

  3. 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

    Time frame: Day 8

  4. 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

    Time frame: Day 15

  5. 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

    Time frame: Day 22

  6. Microbiological eradication

    Proportion of patients with microbiological eradicationat each visit

    Time frame: Day 8, 15, 22

Other outcomes

  1. Cmax

    Maximum plasma concentration

    Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

  2. AUClast

    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

  3. AUCinf

    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

  4. Tmax

    Time to reach Cmax

    Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

  5. t1/2

    Terminal elimination half-life

    Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

  6. CL/F

    Apparent plasma clearance

    Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

  7. Vd/F

    Apparent volume of distribution

    Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

07

Study locations

1 site
  • Chonnam National Universitiy Hospital
    Gwangju, Chonnam 501-757, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2016, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 13, 2016
First posted
Jun 29, 2016
Start
Jun 2016
Primary completionActual
Apr 13, 2017
CompletionActual
Apr 13, 2017
Last update
Jan 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02817347
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Jun 29, 2016
Start date
Jun 2016
Primary completion
Apr 13, 2017
Completion
Apr 13, 2017
Last update
Jan 13, 2022

Study contacts

chulho jang, M.D Ph.D
study chair · Chonnam National Universitiy Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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