Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

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

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

Study Overview

• Status: Unknown
• Conditions: Otitis Media
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Qingdao, China, 266011
    • Recruiting
    • Qingdao Municipal Hospital
    • Contact: Weiguo XUE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.1% Pazufloxacin Mesilate Ear Drops; 10 drips for ear dropping, 10 minutes for ear bath	Drug: 0.1% Pazufloxacin Mesilate Ear Drops
Experimental: 0.3% Pazufloxacin Mesilate Ear Drops; 10 drips for ear dropping, 10 minutes for ear bath	Drug: 0.3% Pazufloxacin Mesilate Ear Drops
Experimental: 0.5% Pazufloxacin Mesilate Ear Drops; 10 drips for ear dropping, 10 minutes for ear bath	Drug: 0.5% Pazufloxacin Mesilate Ear Drops
Active Comparator: Pazufloxacin mesilate injection; 0.3g, 30 minutes for ventricular injection	Drug: Pazufloxacin mesilate injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerance of pazufloxacin mesilate ear drops	Any changes in vital signs; AE/SAE number	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Investigators: Principal Investigator: Weiguo Cue, MD, Qingdao Municipal Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: safety and bioavailability
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Antitubercular Agents; Carbamide Peroxide; Fluoroquinolones; Pazufloxacin
• Other Study ID Numbers: Zhaoke-2015-01