Chronic Suppurative Otitis MediaPhase 1NCT03675841
Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
A Phase 1 study testing Pazufloxacin Mesilate ear drops in people with Chronic Suppurative Otitis Media, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Suppurative Otitis Media
- What is being tested?
- Pazufloxacin Mesilate ear drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2018to 28 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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.
- Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate < 60ml/min).
- Use any local or systemic antibiotics in the first 3 days of the admission.
- Use any quinolones within the first 7 days of admission.
- There were smokers who smoked more than 5 cigarettes a day within one year.
- There was a history of alcoholism and drug abuse within one year.
- Diagnosis of diabetes or poor blood glucose control.
- Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
- Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
- Patients who took part in other clinical trials in the first 3 months.
- Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
- Researchers believe that patients who are not fit to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210029
lei chen, PHD, 13776620807, jspent@126.com
fen shao, PHD, 13851691161, shaofengnj@163.com
About this study
Official title: A Phase I，Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
Read the 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.
- Conditions
- Chronic Suppurative Otitis Media
- Being tested
- Pazufloxacin Mesilate ear drops
- Keywords
- Pazufloxacin Mesilate ear drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pazufloxacin Mesilate ear dropsDrug
Also called ear drops
Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
| Study group | Role | What they receive |
|---|---|---|
| 0.1% single-dose pre | Experimental | Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose Receives: Drug: Pazufloxacin Mesilate ear drops |
| 0.1% single-dose | Experimental | Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose Receives: Drug: Pazufloxacin Mesilate ear drops |
| 0.3% single-dose | Experimental | Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose Receives: Drug: Pazufloxacin Mesilate ear drops |
| 0.5% single-dose | Experimental | Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose Receives: Drug: Pazufloxacin Mesilate ear drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
Measured: Within two days after administration
Secondary outcomes (3)
Cmax
Pharmacokinetics
Measured: Within two days after administration
Tmax
Pharmacokinetics
Measured: Within two days after administration
Area under concentration time curve
Pharmacokinetics
Measured: Within two days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start29 Jul 2018
- Primary completion30 Jan 2019 (estimated)
- Study completion28 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Suppurative Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- lei chen, PHD, Study director, Jiangsu Province People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675841
- Sponsor's protocol ID
- ZK-PZFX-201704
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I，Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
- ClinicalTrials.gov ID
- NCT03675841
- Acronym / sponsor ID
- ZK-PZFX-201704
- Conditions
- Chronic Suppurative Otitis Media
- Keywords
- Pazufloxacin Mesilate ear drops
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2018 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 28 Jun 2019 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.1% single-dose pre | Experimental | Drug: Pazufloxacin Mesilate ear dropsThree subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose |
| 0.1% single-dose | Experimental | Drug: Pazufloxacin Mesilate ear dropsTen subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose |
| 0.3% single-dose | Experimental | Drug: Pazufloxacin Mesilate ear dropsTen subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose |
| 0.5% single-dose | Experimental | Drug: Pazufloxacin Mesilate ear dropsTen subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pazufloxacin Mesilate ear dropsAlso: ear dropsPazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5% | Drug | 0.1% single-dose, 0.1% single-dose pre, 0.3% single-dose, 0.5% single-dose |
Primary outcome
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.
3 secondary outcomes
Cmax
Time frame: Within two days after administration
Tmax
Time frame: Within two days after administration
Area under concentration time curve
Time frame: Within two days after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Suppurative Otitis Media
Not yet recruiting
Acetic Acid Ear Drops Versus 0.3 % Ciprofloxacin for Chronic Suppurative Otitis Media.
Otitis Media Chronic
Not yet recruiting
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
Tympanic Membrane Perforation, Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lei chen, PHD study director
Jiangsu Province People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pazufloxacin Mesilate ear drops in people with Chronic Suppurative Otitis Media, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lei chen, PHD (13776620807, jspent@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Within two days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.