Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

A Phase I，Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.

Study Overview

• Status: Unknown
• Conditions: Chronic Suppurative Otitis Media
• Intervention / Treatment: Drug: Pazufloxacin Mesilate ear drops

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.

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: lei chen, PHD; Phone Number: 13776620807; Email: jspent@126.com
• Study Contact Backup: Name: fen shao, PHD; Phone Number: 13851691161; Email: shaofengnj@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province People's Hospital
      • Contact: lei chen, PHD; Phone Number: 13776620807; Email: jspent@126.com
      • Contact: fen shao, PHD; Phone Number: 13851691161; Email: shaofengnj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age is 18-65 years old. Men and women are not restricted.
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:

1. Quinolone antibiotics allergy and severe allergic constitution.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.1% single-dose pre; Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose	Drug: Pazufloxacin Mesilate ear drops; Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%; Other Names: ear drops
Experimental: 0.1% single-dose; Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose	Drug: Pazufloxacin Mesilate ear drops; Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%; Other Names: ear drops
Experimental: 0.3% single-dose; Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose	Drug: Pazufloxacin Mesilate ear drops; Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%; Other Names: ear drops
Experimental: 0.5% single-dose; Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose	Drug: Pazufloxacin Mesilate ear drops; Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%; Other Names: ear drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Pharmacokinetics	Within two days after administration
Tmax	Pharmacokinetics	Within two days after administration
Area under concentration time curve	Pharmacokinetics	Within two days after administration

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Investigators: Study Director: lei chen, PHD, Jiangsu Province People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2018
• Primary Completion (Anticipated): January 30, 2019
• Study Completion (Anticipated): June 28, 2019

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 16, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Pazufloxacin Mesilate ear drops
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Otorhinolaryngologic Diseases; Ear Diseases; Infections; Otitis; Otitis Media; Suppuration; Otitis Media, Suppurative; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Antitubercular Agents; Carbamide Peroxide; Pazufloxacin
• Other Study ID Numbers: ZK-PZFX-201704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No