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Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

NCT ID: NCT02592096

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Otitis Media

Keywords

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safety and bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.1% Pazufloxacin Mesilate Ear Drops

10 drips for ear dropping, 10 minutes for ear bath

Group Type EXPERIMENTAL

0.1% Pazufloxacin Mesilate Ear Drops

Intervention Type DRUG

0.3% Pazufloxacin Mesilate Ear Drops

10 drips for ear dropping, 10 minutes for ear bath

Group Type EXPERIMENTAL

0.3% Pazufloxacin Mesilate Ear Drops

Intervention Type DRUG

0.5% Pazufloxacin Mesilate Ear Drops

10 drips for ear dropping, 10 minutes for ear bath

Group Type EXPERIMENTAL

0.5% Pazufloxacin Mesilate Ear Drops

Intervention Type DRUG

Pazufloxacin mesilate injection

0.3g, 30 minutes for ventricular injection

Group Type ACTIVE_COMPARATOR

Pazufloxacin mesilate injection

Intervention Type DRUG

Interventions

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0.1% Pazufloxacin Mesilate Ear Drops

Intervention Type DRUG

0.3% Pazufloxacin Mesilate Ear Drops

Intervention Type DRUG

0.5% Pazufloxacin Mesilate Ear Drops

Intervention Type DRUG

Pazufloxacin mesilate injection

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weiguo Cue, MD

Role: PRINCIPAL_INVESTIGATOR

Qingdao Municipal Hospital

Locations

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Qingdao Municipal Hospital

Qingdao, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiguo Xue, MD

Role: CONTACT

Phone: +86-532-82789159

Facility Contacts

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Weiguo XUE, MD

Role: primary

Other Identifiers

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Zhaoke-2015-01

Identifier Type: -

Identifier Source: org_study_id