Otitis MediaPhase 1NCT02592096
Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol
A Phase 1 study testing 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops and 0.5% Pazufloxacin Mesilate Ear Drops in people with Otitis Media, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops and 0.5% Pazufloxacin Mesilate Ear Drops
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
Weiguo Xue, MD contact
China1 site, 1 recruiting
- Recruiting
Qingdao Municipal Hospital
Qingdao, 266011
Weiguo XUE, MD
About this study
Official title: A Single Dose Phase I Clinical Study of Pazufloxacin Mesilate Ear Drops for the Patients With Otitis Media
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
- Being tested
- 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops, 0.5% Pazufloxacin Mesilate Ear Drops, Pazufloxacin mesilate injection
- Keywords
- safety and bioavailability
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% Pazufloxacin Mesilate Ear DropsDrug
0.3% Pazufloxacin Mesilate Ear DropsDrug
0.5% Pazufloxacin Mesilate Ear DropsDrug
Pazufloxacin mesilate injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.1% Pazufloxacin Mesilate Ear Drops | Experimental | 10 drips for ear dropping, 10 minutes for ear bath Receives: Drug: 0.1% Pazufloxacin Mesilate Ear Drops |
| 0.3% Pazufloxacin Mesilate Ear Drops | Experimental | 10 drips for ear dropping, 10 minutes for ear bath Receives: Drug: 0.3% Pazufloxacin Mesilate Ear Drops |
| 0.5% Pazufloxacin Mesilate Ear Drops | Experimental | 10 drips for ear dropping, 10 minutes for ear bath Receives: Drug: 0.5% Pazufloxacin Mesilate Ear Drops |
| Pazufloxacin mesilate injection | Active comparator | 0.3g, 30 minutes for ventricular injection Receives: Drug: Pazufloxacin mesilate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerance of pazufloxacin mesilate ear drops
Any changes in vital signs; AE/SAE number
Measured: 24 hours
Secondary outcomes (2)
PK of pazufloxacin mesilate ear drops
blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. AUC will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.
Measured: 24 hours
PK of pazufloxacin mesilate ear drops
blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. Cmax will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiguo Cue, MD, Principal investigator, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592096
- Sponsor's protocol ID
- Zhaoke-2015-01
- Status last verified
- Oct 2015
- First submitted
- 15 Jul 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Phase I Clinical Study of Pazufloxacin Mesilate Ear Drops for the Patients With Otitis Media
- ClinicalTrials.gov ID
- NCT02592096
- Acronym / sponsor ID
- Zhaoke-2015-01
- Conditions
- Otitis Media
- Keywords
- safety and bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.1% Pazufloxacin Mesilate Ear Drops | Experimental | Drug: 0.1% Pazufloxacin Mesilate Ear Drops10 drips for ear dropping, 10 minutes for ear bath |
| 0.3% Pazufloxacin Mesilate Ear Drops | Experimental | Drug: 0.3% Pazufloxacin Mesilate Ear Drops10 drips for ear dropping, 10 minutes for ear bath |
| 0.5% Pazufloxacin Mesilate Ear Drops | Experimental | Drug: 0.5% Pazufloxacin Mesilate Ear Drops10 drips for ear dropping, 10 minutes for ear bath |
| Pazufloxacin mesilate injection | Active comparator | Drug: Pazufloxacin mesilate injection0.3g, 30 minutes for ventricular injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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);
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 |
|---|---|---|
| 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 |
Primary outcome
safety and tolerance of pazufloxacin mesilate ear drops
Time frame: 24 hours
Any changes in vital signs; AE/SAE number
2 secondary outcomes
PK of pazufloxacin mesilate ear drops
Time frame: 24 hours
PK of pazufloxacin mesilate ear drops
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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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.
Weiguo Xue, MD contact
Weiguo Cue, MD principal investigator
Qingdao Municipal 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 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops and 0.5% Pazufloxacin Mesilate Ear Drops in people with 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 3 inclusion and 13 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 30 Oct 2015. 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 Weiguo Xue, MD (+86-532-82789159), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerance of pazufloxacin mesilate ear drops (time frame: 24 hours). 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 30 Oct 2015.