Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Primary Purpose
Chronic Suppurative Otitis Media
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pazufloxacin Mesilate ear drops
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Suppurative Otitis Media focused on measuring Pazufloxacin Mesilate ear drops
Eligibility Criteria
Inclusion Criteria:
- Age is 18-65 years old. Men and women are not restricted.
- Clinical diagnosis of simple chronic suppurative otitis media with ear effusion secretion, tympanic membrane perforation about 2 mm, the need for local use of antibiotics in patients.
- Voluntarily sign written informed consent.
- Non-breast-feeding women volunteered to take appropriate contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) during the study period (screening period to one week after administration). Men are willing to use approved contraceptive methods (including the use of condoms and spermicides or the use of oral, implantable or injectable contraceptives by their partners, intrauterine devices, diaphragms and spermicides) or sexual partner infertility.
Exclusion Criteria:
- Quinolone antibiotics allergy and severe allergic constitution.
- During the study, ear fluid could not be collected.
- Patients with severe need for systemic use of antibiotics.
- Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
- Patients with cholesteatoma.
- Complicated with symptoms of extraaural infection (such as periaural cellulitis, mumps) or intracranial and extracranial complications (such as meningitis, brain abscess, thrombophlebitis of sigmoid sinus, subperiosteal abscess of the ear, Bezold's abscess of the neck).
- Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
- People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.
- Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate < 60ml/min).
- Use any local or systemic antibiotics in the first 3 days of the admission.
- Use any quinolones within the first 7 days of admission.
- There were smokers who smoked more than 5 cigarettes a day within one year.
- There was a history of alcoholism and drug abuse within one year.
- Diagnosis of diabetes or poor blood glucose control.
- Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
- Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
- Patients who took part in other clinical trials in the first 3 months.
- Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
- Researchers believe that patients who are not fit to participate in this clinical trial.
Sites / Locations
- Jiangsu Province People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
0.1% single-dose pre
0.1% single-dose
0.3% single-dose
0.5% single-dose
Arm Description
Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
Secondary Outcome Measures
Cmax
Pharmacokinetics
Tmax
Pharmacokinetics
Area under concentration time curve
Pharmacokinetics
Full Information
NCT ID
NCT03675841
First Posted
September 5, 2018
Last Updated
September 24, 2018
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT03675841
Brief Title
Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Official Title
A Phase I,Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Anticipated)
Study Completion Date
June 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
Detailed Description
The test group was completed in sequence from low to high concentrations, and safety tolerance was assessed after administration in one concentration group to determine whether to conduct follow-up group studies and, if necessary, adjust sampling time points according to pre-experimental results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Suppurative Otitis Media
Keywords
Pazufloxacin Mesilate ear drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.1% single-dose pre
Arm Type
Experimental
Arm Description
Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Arm Title
0.1% single-dose
Arm Type
Experimental
Arm Description
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Arm Title
0.3% single-dose
Arm Type
Experimental
Arm Description
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose
Arm Title
0.5% single-dose
Arm Type
Experimental
Arm Description
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose
Intervention Type
Drug
Intervention Name(s)
Pazufloxacin Mesilate ear drops
Other Intervention Name(s)
ear drops
Intervention Description
Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5%
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
Time Frame
Within two days after administration
Secondary Outcome Measure Information:
Title
Cmax
Description
Pharmacokinetics
Time Frame
Within two days after administration
Title
Tmax
Description
Pharmacokinetics
Time Frame
Within two days after administration
Title
Area under concentration time curve
Description
Pharmacokinetics
Time Frame
Within two days after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age is 18-65 years old. Men and women are not restricted.
Clinical diagnosis of simple chronic suppurative otitis media with ear effusion secretion, tympanic membrane perforation about 2 mm, the need for local use of antibiotics in patients.
Voluntarily sign written informed consent.
Non-breast-feeding women volunteered to take appropriate contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) during the study period (screening period to one week after administration). Men are willing to use approved contraceptive methods (including the use of condoms and spermicides or the use of oral, implantable or injectable contraceptives by their partners, intrauterine devices, diaphragms and spermicides) or sexual partner infertility.
Exclusion Criteria:
Quinolone antibiotics allergy and severe allergic constitution.
During the study, ear fluid could not be collected.
Patients with severe need for systemic use of antibiotics.
Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
Patients with cholesteatoma.
Complicated with symptoms of extraaural infection (such as periaural cellulitis, mumps) or intracranial and extracranial complications (such as meningitis, brain abscess, thrombophlebitis of sigmoid sinus, subperiosteal abscess of the ear, Bezold's abscess of the neck).
Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.
Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate < 60ml/min).
Use any local or systemic antibiotics in the first 3 days of the admission.
Use any quinolones within the first 7 days of admission.
There were smokers who smoked more than 5 cigarettes a day within one year.
There was a history of alcoholism and drug abuse within one year.
Diagnosis of diabetes or poor blood glucose control.
Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
Patients who took part in other clinical trials in the first 3 months.
Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
Researchers believe that patients who are not fit to participate in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lei chen, PHD
Phone
13776620807
Email
jspent@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
fen shao, PHD
Phone
13851691161
Email
shaofengnj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lei chen, PHD
Organizational Affiliation
Jiangsu Province People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu Province People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lei chen, PHD
Phone
13776620807
Email
jspent@126.com
First Name & Middle Initial & Last Name & Degree
fen shao, PHD
Phone
13851691161
Email
shaofengnj@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
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