Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675841
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.

Condition or disease Intervention/treatment Phase
Chronic Suppurative Otitis Media Drug: Pazufloxacin Mesilate ear drops Phase 1

Detailed Description:
The test group was completed in sequence from low to high concentrations, and safety tolerance was assessed after administration in one concentration group to determine whether to conduct follow-up group studies and, if necessary, adjust sampling time points according to pre-experimental results.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I,Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Actual Study Start Date : July 29, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: 0.1% single-dose pre
Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Drug: Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5%
Other Name: ear drops

Experimental: 0.1% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
Drug: Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5%
Other Name: ear drops

Experimental: 0.3% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose
Drug: Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5%
Other Name: ear drops

Experimental: 0.5% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose
Drug: Pazufloxacin Mesilate ear drops
Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5%
Other Name: ear drops




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Within two days after administration ]
    Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Within two days after administration ]
    Pharmacokinetics

  2. Tmax [ Time Frame: Within two days after administration ]
    Pharmacokinetics

  3. Area under concentration time curve [ Time Frame: Within two days after administration ]
    Pharmacokinetics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age is 18-65 years old. Men and women are not restricted.
  2. Clinical diagnosis of simple chronic suppurative otitis media with ear effusion secretion, tympanic membrane perforation about 2 mm, the need for local use of antibiotics in patients.
  3. Voluntarily sign written informed consent.
  4. Non-breast-feeding women volunteered to take appropriate contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) during the study period (screening period to one week after administration). Men are willing to use approved contraceptive methods (including the use of condoms and spermicides or the use of oral, implantable or injectable contraceptives by their partners, intrauterine devices, diaphragms and spermicides) or sexual partner infertility.

Exclusion Criteria:

  1. Quinolone antibiotics allergy and severe allergic constitution.
  2. During the study, ear fluid could not be collected.
  3. Patients with severe need for systemic use of antibiotics.
  4. Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
  5. Patients with cholesteatoma.
  6. Complicated with symptoms of extraaural infection (such as periaural cellulitis, mumps) or intracranial and extracranial complications (such as meningitis, brain abscess, thrombophlebitis of sigmoid sinus, subperiosteal abscess of the ear, Bezold's abscess of the neck).
  7. Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
  8. People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.
  9. Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate < 60ml/min).
  10. Use any local or systemic antibiotics in the first 3 days of the admission.
  11. Use any quinolones within the first 7 days of admission.
  12. There were smokers who smoked more than 5 cigarettes a day within one year.
  13. There was a history of alcoholism and drug abuse within one year.
  14. Diagnosis of diabetes or poor blood glucose control.
  15. Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
  16. Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
  17. Patients who took part in other clinical trials in the first 3 months.
  18. Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
  19. Researchers believe that patients who are not fit to participate in this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675841


Contacts
Layout table for location contacts
Contact: lei chen, PHD 13776620807 jspent@126.com
Contact: fen shao, PHD 13851691161 shaofengnj@163.com

Locations
Layout table for location information
China, Jiangsu
Jiangsu Province People's Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: lei chen, PHD    13776620807    jspent@126.com   
Contact: fen shao, PHD    13851691161    shaofengnj@163.com   
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
Layout table for investigator information
Study Director: lei chen, PHD Jiangsu Province People's Hospital

Layout table for additonal information
Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03675841     History of Changes
Other Study ID Numbers: ZK-PZFX-201704
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee's Pharmaceutical Limited:
Pazufloxacin Mesilate ear drops
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Otitis Media, Suppurative
Otitis
Otitis Media
Ear Diseases
Suppuration
Otorhinolaryngologic Diseases
Inflammation
Pathologic Processes
Carbamide Peroxide
Pazufloxacin
Fluoroquinolones
Anti-Infective Agents, Local
Anti-Infective Agents
Antitubercular Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors