Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

NCT02592096 | Unknown Phase 1

• 1 other identifier: Zhaoke-2015-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Otitis Media

Keywords

safety and bioavailability

Outcome Measures

Primary Outcomes (1)

• safety and tolerance of pazufloxacin mesilate ear drops

  Any changes in vital signs; AE/SAE number

  24 hours

Secondary Outcomes (2)

• PK of pazufloxacin mesilate ear drops

  24 hours

• PK of pazufloxacin mesilate ear drops

  24 hours

Study Arms (4)

0.1% Pazufloxacin Mesilate Ear Drops

EXPERIMENTAL

10 drips for ear dropping, 10 minutes for ear bath

Drug: 0.1% Pazufloxacin Mesilate Ear Drops

0.3% Pazufloxacin Mesilate Ear Drops

EXPERIMENTAL

10 drips for ear dropping, 10 minutes for ear bath

Drug: 0.3% Pazufloxacin Mesilate Ear Drops

0.5% Pazufloxacin Mesilate Ear Drops

EXPERIMENTAL

10 drips for ear dropping, 10 minutes for ear bath

Drug: 0.5% Pazufloxacin Mesilate Ear Drops

Pazufloxacin mesilate injection

ACTIVE COMPARATOR

0.3g, 30 minutes for ventricular injection

Drug: Pazufloxacin mesilate injection

Interventions

0.1% Pazufloxacin Mesilate Ear Drops DRUG

0.1% Pazufloxacin Mesilate Ear Drops

0.3% Pazufloxacin Mesilate Ear Drops DRUG

0.3% Pazufloxacin Mesilate Ear Drops

0.5% Pazufloxacin Mesilate Ear Drops DRUG

0.5% Pazufloxacin Mesilate Ear Drops

Pazufloxacin mesilate injection DRUG

Pazufloxacin mesilate injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years old, both gender;
• Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents;
• Written informed consent form.

You may not qualify if:

• Allergic to quinolones antibiotics or severe allergic constitution;
• Not able to collect otorrhea during the trial;
• High severity with the need of combined antibiotics treatment;
• Induced by pathogens, e.g.: fungus, virus (myringitis bullosa);
• 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);
• Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system;
• Life-threatening disease, e.g.: malignant tumor or AIDS.
• Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr \> normal maximum level);
• Confirmed or suspected of alcohol/drug abuse record;
• Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction;
• Feminine patients who are in gestational, lactation period or having a birth plan in short-term;
• Enrolled into other clinical trial in the past 3 months;
• Not suitable for this trial according to investigator's judgment;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Qingdao Municipal Hospital

Qingdao, 266011, China

RECRUITING

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Weiguo Cue, MD

  Qingdao Municipal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiguo Xue, MD

CONTACT

+86-532-82789159

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: October 30, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

CN (1)