UnknownPhase 1

Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

China33 participantsStarted 2018-07-29

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Age is 18-65 years old. Men and women are not restricted.
✓. 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.
✓. Voluntarily sign written informed consent.
✓. 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

✕. Quinolone antibiotics allergy and severe allergic constitution.
✕. During the study, ear fluid could not be collected.
✕. Patients with severe need for systemic use of antibiotics.
✕. Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
✕. Patients with cholesteatoma.
✕. 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).
✕. Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
✕. People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: Within two days after administration

Trial details

NCT IDNCT03675841

SponsorLee's Pharmaceutical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-30

Contact for this trial

lei chen, PHD

13776620807 jspent@126.com

View on ClinicalTrials.gov More Chronic Suppurative Otitis Media trials