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

Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02817347
• Other study ID #: YH1177-201
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otorrhea

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