Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Lee's Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Otitis Media

Treatments: Drug: 0.3% Pazufloxacin Mesilate Ear Drops; Drug: 0.5% Pazufloxacin Mesilate Ear Drops; Drug: Pazufloxacin mesilate injection; Drug: 0.1% Pazufloxacin Mesilate Ear Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT02592096

Zhaoke-2015-01

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

0.1% Pazufloxacin Mesilate Ear Drops

Experimental group

Description:

10 drips for ear dropping, 10 minutes for ear bath

Treatment:

Drug: 0.1% Pazufloxacin Mesilate Ear Drops

0.3% Pazufloxacin Mesilate Ear Drops

Experimental group

Description:

10 drips for ear dropping, 10 minutes for ear bath

Treatment:

Drug: 0.3% Pazufloxacin Mesilate Ear Drops

0.5% Pazufloxacin Mesilate Ear Drops

Experimental group

Description:

10 drips for ear dropping, 10 minutes for ear bath

Treatment:

Drug: 0.5% Pazufloxacin Mesilate Ear Drops

Pazufloxacin mesilate injection

Active Comparator group

Description:

0.3g, 30 minutes for ventricular injection

Treatment:

Drug: Pazufloxacin mesilate injection