Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 433 for:    OTITIS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817347
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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.

Condition or disease Intervention/treatment Phase
Otitis Media Otorrhea Drug: piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1% Drug: piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1% Drug: piperacillin 2% + tazobactam 0.25% Drug: piperacillin 4% + tazobactam 0.5% Drug: piperacillin 8% + tazobactam 1.0% Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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%



Primary Outcome Measures :
  1. proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Proportion of patients with cessation of otorrhea on Day 8 as evidenced by otoscopy [ Time Frame: Day 8 ]
  2. 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 [ Time Frame: Day 8 ]
    'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale

  4. Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy [ Time Frame: Day 15 ]
    'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale

  5. Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy [ Time Frame: Day 22 ]
    'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale

  6. Proportion of patients with microbiological eradication at each visit [ Time Frame: Day 8 ]
  7. Proportion of patients with microbiological eradication at each visit [ Time Frame: Day 15 ]
  8. Proportion of patients with microbiological eradication at each visit [ Time Frame: Day 22 ]

Other Outcome Measures:
  1. Time to cessation of otorrhea as recorded by the patient via the patient's diary [ Time Frame: Day 8 ]
  2. Time to cessation of otorrhea as recorded by the patient via the patient's diary [ Time Frame: Day 15 ]
  3. Time to cessation of otorrhea as recorded by the patient via the patient's diary [ Time Frame: Day 22 ]
  4. Proportion of patients with microbiological eradication(bacterial culture test) by type of randomization pathogen at each visit. [ Time Frame: Day 8 ]
  5. Proportion of patients with microbiological eradication(bacterial culture test) by type of randomization pathogen at each visit. [ Time Frame: Day 15 ]
  6. Proportion of patients with microbiological eradication(bacterial culture test) by type of randomization pathogen at each visit. [ Time Frame: Day 22 ]
  7. Cmax [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]
  8. AUClast [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]
  9. AUCinf [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]
  10. Tmax [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]
  11. t1/2 [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]
  12. CL/F [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]
  13. Vd/F [ Time Frame: pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817347


Locations
Layout table for location information
Korea, Republic of
Chonnam National Universitiy Hospital
Gwang-ju, Chonnam, Korea, Republic of, 501-757
Sponsors and Collaborators
Yuhan Corporation
Investigators
Layout table for investigator information
Study Chair: chulho jang, M.D Ph.D Chonnam National Universitiy Hospital

Layout table for additonal information
Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02817347     History of Changes
Other Study ID Numbers: YH1177-201
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Tazobactam
Piperacillin
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors