Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
NCT ID: NCT03675841
Last Updated: 2018-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
33 participants
INTERVENTIONAL
2018-07-29
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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0.1% single-dose pre
Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
0.1% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
0.3% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose
Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
0.5% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose
Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
Interventions
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Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Voluntarily sign written informed consent.
4. 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
2. During the study, ear fluid could not be collected.
3. Patients with severe need for systemic use of antibiotics.
4. Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
5. Patients with cholesteatoma.
6. 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).
7. Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
8. People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.
9. Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate \< 60ml/min).
10. Use any local or systemic antibiotics in the first 3 days of the admission.
11. Use any quinolones within the first 7 days of admission.
12. There were smokers who smoked more than 5 cigarettes a day within one year.
13. There was a history of alcoholism and drug abuse within one year.
14. Diagnosis of diabetes or poor blood glucose control.
15. Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
16. Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
17. Patients who took part in other clinical trials in the first 3 months.
18. Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
19. Researchers believe that patients who are not fit to participate in this clinical trial.
18 Years
65 Years
ALL
Yes
Sponsors
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Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
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Principal Investigators
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lei chen, PHD
Role: STUDY_DIRECTOR
Jiangsu Province People's Hospital
Locations
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Jiangsu Province People's Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZK-PZFX-201704
Identifier Type: -
Identifier Source: org_study_id
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