Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

NCT03675841 | Unknown Phase 1

• 1 other identifier: ZK-PZFX-201704
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Suppurative Otitis Media

Keywords

Pazufloxacin Mesilate ear drops

Outcome Measures

Primary Outcomes (1)

• 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.

  Within two days after administration

Secondary Outcomes (3)

• Cmax

  Within two days after administration

• Tmax

  Within two days after administration

• Area under concentration time curve

  Within two days after administration

Study Arms (4)

0.1% single-dose pre

EXPERIMENTAL

Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose

Drug: Pazufloxacin Mesilate ear drops

0.1% single-dose

EXPERIMENTAL

Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose

Drug: Pazufloxacin Mesilate ear drops

0.3% single-dose

EXPERIMENTAL

Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose

Drug: Pazufloxacin Mesilate ear drops

0.5% single-dose

EXPERIMENTAL

Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose

Drug: Pazufloxacin Mesilate ear drops

Interventions

Pazufloxacin Mesilate ear drops DRUG

Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%

Also known as: ear drops

0.1% single-dose; 0.1% single-dose pre; 0.3% single-dose; 0.5% single-dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Jiangsu Province People's Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

Urea

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals

Study Officials

• lei chen, PHD

  Jiangsu Province People's Hospital

  STUDY DIRECTOR

Central Study Contacts

lei chen, PHD

CONTACT

13776620807; jspent@126.com

fen shao, PHD

CONTACT

13851691161; shaofengnj@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 18, 2018
• Study Start: July 29, 2018
• Primary Completion: January 30, 2019
• Study Completion: June 28, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)