Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Otitis Media Clinical Trial

Official title:

A Single Dose Phase I Clinical Study of Pazufloxacin Mesilate Ear Drops for the Patients With Otitis Media

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592096
• Other study ID #: Zhaoke-2015-01
• Status: Recruiting
• Phase: Phase 1
• First received: July 15, 2015
• Last updated: October 28, 2015
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Lee's Pharmaceutical Limited
• Contact: Weiguo Xue, MD
• Phone: +86-532—82789159
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Drug:
• 0.1% Pazufloxacin Mesilate Ear Drops

• 0.3% Pazufloxacin Mesilate Ear Drops

• 0.5% Pazufloxacin Mesilate Ear Drops

• Pazufloxacin mesilate injection

Locations

Country	Name	City	State
China	Qingdao Municipal Hospital	Qingdao

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerance of pazufloxacin mesilate ear drops	Any changes in vital signs; AE/SAE number	24 hours	Yes
Secondary	PK of pazufloxacin mesilate ear drops	blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. AUC will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.	24 hours	No
Secondary	PK of pazufloxacin mesilate ear drops	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.	24 hours