Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Carbamide Peroxide; Fluoroquinolones; Pazufloxacin

Criteria

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;