Otitis MediaPhase 1/2NCT02817347

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

A Phase 1/2 study testing piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%, piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1% and piperacillin 2% + tazobactam 0.25% in people with Otitis Media and Otorrhea, run by Yuhan Corporation at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Otitis Media, Otorrhea
What is being tested?: piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%, piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1% and piperacillin 2% + tazobactam 0.25%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 1 siteSouth Korea
Study dates: Jun 2016to 13 Apr 2017
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 22Show fewer

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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chonnam National Universitiy Hospital
Gwangju, Chonnam, 501-757

Other trials in South Korea

About this study

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

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.

Conditions: Otitis Media, Otorrhea
Being tested: 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%
Medical subject headings: Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%Drug
Also called YH1177 (4/0.5%+0.1%)
piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%Drug
Also called YH1177 (8/1.0%+0.1%)
piperacillin 2% + tazobactam 0.25%Drug
Also called YH1177-D (2/0.25%)
piperacillin 4% + tazobactam 0.5%Drug
Also called YH1177-D (4/0.5%)
piperacillin 8% + tazobactam 1.0%Drug
Also called YH1177-D (8/1.0 %)

Study groups in NCT02817347
Study group	Role	What they receive
YH1177 (4/0.5%+0.1%)	Experimental	piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1% Receives: Drug: piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%
YH1177 (8/1.0%+0.1%)	Experimental	piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1% Receives: Drug: piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%
YH1177-D (2/0.25%)	Experimental	piperacillin 2% + tazobactam 0.25% Receives: Drug: piperacillin 2% + tazobactam 0.25%
YH1177-D (4/0.5%)	Experimental	piperacillin 4% + tazobactam 0.5% Receives: Drug: piperacillin 4% + tazobactam 0.5%
YH1177-D (8/1.0%)	Experimental	piperacillin 8% + tazobactam 1.0% Receives: Drug: piperacillin 8% + tazobactam 1.0%

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 15

Secondary outcomes (6)

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.
Measured: Day 8
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.
Measured: Day 22
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
Measured: Day 8
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
Measured: Day 15
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
Measured: Day 22
Microbiological eradication
Proportion of patients with microbiological eradicationat each visit
Measured: Day 8, 15, 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201613 Apr 2017

First posted29 Jun 2016 (estimated)
Study startJun 2016
Primary completion13 Apr 2017
Study completion13 Apr 2017

Why it stopped: Sponsor's decision for the Drug Development.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Otitis MediaStudies of the same condition, open and under way.
More trials run by Yuhan CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02817347
Sponsor's protocol ID: YH1177-201
Status last verified: Dec 2021
First submitted: 13 Jun 2016
Last updated: 13 Jan 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02817347
Acronym / sponsor ID: YH1177-201
Conditions: Otitis Media, Otorrhea
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's decision for the Drug Development.
Enrolment: 135 participants (actual)
Lead sponsor: Yuhan CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: 13 Apr 2017 (actual)
Study completion: 13 Apr 2017 (actual)
First posted: 29 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
YH1177 (4/0.5%+0.1%)	Experimental	Drug: piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%
YH1177 (8/1.0%+0.1%)	Experimental	Drug: piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%
YH1177-D (2/0.25%)	Experimental	Drug: piperacillin 2% + tazobactam 0.25%piperacillin 2% + tazobactam 0.25%
YH1177-D (4/0.5%)	Experimental	Drug: piperacillin 4% + tazobactam 0.5%piperacillin 4% + tazobactam 0.5%
YH1177-D (8/1.0%)	Experimental	Drug: piperacillin 8% + tazobactam 1.0%piperacillin 8% + tazobactam 1.0%

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (22 listed)

Excluded Disease
Medical History and Concurrent Disease
Physical and Laboratory Test Results
a)Clinically significant finding based on the principal investigator/investigator's opinion.
Allergies and Adverse Drug Reactions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%Also: YH1177 (4/0.5%+0.1%)	Drug	YH1177 (4/0.5%+0.1%)
piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%Also: YH1177 (8/1.0%+0.1%)	Drug	YH1177 (8/1.0%+0.1%)
piperacillin 2% + tazobactam 0.25%Also: YH1177-D (2/0.25%)	Drug	YH1177-D (2/0.25%)
piperacillin 4% + tazobactam 0.5%Also: YH1177-D (4/0.5%)	Drug	YH1177-D (4/0.5%)
piperacillin 8% + tazobactam 1.0%Also: YH1177-D (8/1.0 %)	Drug	YH1177-D (8/1.0%)

Primary outcome

The proportion of patients achieving cessation of otorrhea on Day 15.
Time frame: Day 15
The proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy

6 secondary outcomes

The proportion of patients with cessation of otorrhea on Day 8.
Time frame: Day 8
The proportion of patients with cessation of otorrhea on Day 22.
Time frame: Day 22
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
Time frame: Day 8
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
Time frame: Day 15
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
Time frame: Day 22
Microbiological eradication
Time frame: Day 8, 15, 22

Results and safety

The study was stopped early (reason given: Sponsor's decision for the Drug Development.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.

Related trials for Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

chulho jang, M.D Ph.D study chair

Chonnam National Universitiy Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor's decision for the Drug Development.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients achieving cessation of otorrhea on Day 15. (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.