Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Phase 1

• Conditions: Otitis Media
• Interventions: Drug: 0.1% Pazufloxacin Mesilate Ear Drops; Drug: 0.3% Pazufloxacin Mesilate Ear Drops; Drug: 0.5% Pazufloxacin Mesilate Ear Drops; Drug: Pazufloxacin mesilate injection

• Registration Number: NCT02592096
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief Summary

To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-28
• Last Update Submitted: 2015-10-28
• Study First Posted: 2015-10-30
• Last Update Posted: 2015-10-30
• Primary Completion: 2016-01
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Aged 18-65 years old, both gender;
2. Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents;
3. Written informed consent form.

Exclusion Criteria

1. Allergic to quinolones antibiotics or severe allergic constitution;
2. Not able to collect otorrhea during the trial;
3. High severity with the need of combined antibiotics treatment;
4. Induced by pathogens, e.g.: fungus, virus (myringitis bullosa);
5. Combined otitis externa (e.g.: ear cellulitis, mumps), intracranial or extracranial complication (meningitis, cerebral abscess, thrombophlebitis of sigmoid sinus, Bezold's abscess, ear subperiosteal abscess);
6. Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system;
7. Life-threatening disease, e.g.: malignant tumor or AIDS.
8. Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr > normal maximum level);
9. Confirmed or suspected of alcohol/drug abuse record;
10. Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction;
11. Feminine patients who are in gestational, lactation period or having a birth plan in short-term;
12. Enrolled into other clinical trial in the past 3 months;
13. Not suitable for this trial according to investigator's judgment;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1% Pazufloxacin Mesilate Ear Drops	0.1% Pazufloxacin Mesilate Ear Drops	10 drips for ear dropping, 10 minutes for ear bath
0.3% Pazufloxacin Mesilate Ear Drops	0.3% Pazufloxacin Mesilate Ear Drops	10 drips for ear dropping, 10 minutes for ear bath
0.5% Pazufloxacin Mesilate Ear Drops	0.5% Pazufloxacin Mesilate Ear Drops	10 drips for ear dropping, 10 minutes for ear bath
Pazufloxacin mesilate injection	Pazufloxacin mesilate injection	0.3g, 30 minutes for ventricular injection

Primary Outcome Measures

Name	Time	Method
safety and tolerance of pazufloxacin mesilate ear drops	24 hours	Any changes in vital signs; AE/SAE number

Secondary Outcome Measures

Name	Time	Method
PK of pazufloxacin mesilate ear drops	24 hours	blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. Cmax will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.

Trial Locations

Locations (1)

Qingdao Municipal Hospital; 🇨🇳 Qingdao, China