Otitis Media in Patients With Tympanostomy TubesPhase 3NCT01994642
Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
A Phase 3 study testing Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension and CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) in people with Otitis Media in Patients With Tympanostomy Tubes, run by Par Pharmaceutical, Inc. at 23 sites in United States.
Trial summary
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Otitis Media in Patients With Tympanostomy Tubes
- What is being tested?
- Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension and CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2013to Mar 2015
- Phase
- Phase 3
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female aged 6 months-12 years of age inclusive.
- Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations.
- Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format.
- Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).
- Clinical signs and symptoms consistent with acute bacterial otitis media in at least one ear and a score of at least 2 for otorrhea using the following scale 0=none, 1=mild, 2=moderate, 3=severe, (see Appendix A for rating scale and severity definitions).
- Otorrhea has been present for 21 days or less.
- The presence of infection confirmed by a positive bacterial culture for the presence of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Pseudomonas aeruginosa. As the results of the bacterial culture will not be immediately known, patients who meet all the other inclusion/exclusion criteria may be enrolled in the study pending the results of the bacterial culture.
Who cannot join
- Tympanostomy tube placement occurred within 3 days or less of screening visit.
- Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.
- Signs and symptoms of otitis media for longer than 21 days prior to being screened for inclusion in the study.
- Since the insertion of the tympanostomy tube(s), more than 1 previous episode of otitis media within the previous 3 months or more than 4 episodes within the previous 12 months.
- Provided any therapeutic drug treatment for current episode of otitis media within the previous 14 days.
- Current or previous history of any otologic surgery other than insertion/removal of tympanostomy tubes in infected ear(s).
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- Clinical diagnosis that suggests current signs or symptoms are not caused by acute bacterial otitis media e.g. otitis externa
- Clinical diagnosis of malignant otitis externa
- Mastoid cavities, stenosis, exostosis or tumors of either ear or other noninfectious diseases of either ear.
- Suspected concurrent fungal or viral infection (e.g. herpes simplex) of either ear.
- Dermatitis of the infected ear such as psoriasis or seborrhea that would complicate evaluations.
- Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
- Significant underlying disease such as diabetes, HIV or other immunocompromised conditions or receiving therapy that may cause patient to be immunocompromised.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- Investigator believes that severity of infection is such that systemic antibiotics would be the preferred treatment option.
- Use of any systemic antibacterial products or topical antibacterial products in the ear(s) within 14 days of screening for the study.
- Use of any systemic anti-inflammatory products or topical anti-inflammatory products in the ear(s) (such as corticosteroids and NSAIDs) within 7 days of screening for the study.
- Use of any topical or otic medication in the affected ear within 7 days prior to screening.
- Use of any astringents such as vinegar, alcohol or medicated cleansing or swabbing of the ear within 48 hours of the baseline bacterial culture swab.
- Receipt of any drug or device as part of a research study within 30 days prior to dosing.
- Previous participation in this study.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Rainbow Research, Inc
Barnwell, South Carolina, 29812
Birmingham Pediatrics
Birmingham, Alabama, 32505
Dr. Craig Spiegel
Bridgeton, Missouri, 63044
PMG Research of Bristol
Bristol, Tennessee, 37620
Eagle Family Medical Associates
Crossville, Tennessee, 38555
Cyn3gry
Gresham, Oregon, 97030
Dr. Scott Mathei
Henderson, Nevada, 89704
Accecss MD, Clinical Resarch
Huber Heights, Ohio, 45424
Alliance Research
Long Beach, California, 90813
The Education and Research Foundation, Inc
Lynchburg, Virginia, 24501
Agave Clinical Ressearch
Mesa, Arizona, 85202
San Marcus Research Clinic
Miami, Florida, 33015
Florida Medical Center and Research Inc.
Miami, Florida, 33142
South Miami Clinical Research Group
Miami, Florida, 33142
Miami Dade Medical Resarch Institute
Miami, Florida, 33176
Global Health Research Center
Miami Lakes, Florida, 33016
Dr. John Ansley
Orangeburg, South Carolina, 29118
Research Integrity
Owensboro, Kentucky, 42303
Arizona Center for Clinical Trials
Phoenix, Arizona, 85003
Spartanburg and Greer ENT
Spartanburg, South Carolina, 29303
Visions Clinical Research, Tuscon
Tucson, Arizona, 85712
Piedmont Ear Nose and Throat Associates, PA
Winston-Salem, North Carolina, 27103
Winter Park Clinical Research
Winter Park, Florida, 32792
About this study
Official title: A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.
- Being tested
- Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension, CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%), Placebo Sterile Otic Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspensionDrug
CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)Drug
Placebo Sterile Otic SuspensionDrug
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) Receives: Drug: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) |
| Placebo | Placebo comparator | Placebo Sterile Otic Suspension Receives: Drug: Placebo Sterile Otic Suspension |
| Test | Experimental | Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension Receives: Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
A patient who is considered a "clinical success" at Visit 4 (Test of Cure/End of Study) will have no signs or symptoms of active AOMT that were present at baseline nor any new signs or symptoms of AOMT have developed
Measured: Day 14-21
Secondary outcomes (1)
Cessation of Otorrhea
Measured: Day 14-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media in Patients With Tympanostomy TubesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
- Investigators
- Chandra Vattikonda, Ph.D., Study director, Par Pharamceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994642
- Sponsor's protocol ID
- 71205503
- Status last verified
- Sep 2017
- First submitted
- 20 Nov 2013
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes
- ClinicalTrials.gov ID
- NCT01994642
- Acronym / sponsor ID
- 71205503
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Nov 2013 (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.
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Drug: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) |
| Placebo | Placebo comparator | Drug: Placebo Sterile Otic SuspensionPlacebo Sterile Otic Suspension |
| Test | Experimental | Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspensionCiprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female aged 6 months-12 years of age inclusive.
- Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations.
- Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format.
- Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).
- Clinical signs and symptoms consistent with acute bacterial otitis media in at least one ear and a score of at least 2 for otorrhea using the following scale 0=none, 1=mild, 2=moderate, 3=severe, (see Appendix A for rating scale and severity definitions).
Key exclusion criteria (21 listed)
- Tympanostomy tube placement occurred within 3 days or less of screening visit.
- Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.
- Signs and symptoms of otitis media for longer than 21 days prior to being screened for inclusion in the study.
- Since the insertion of the tympanostomy tube(s), more than 1 previous episode of otitis media within the previous 3 months or more than 4 episodes within the previous 12 months.
- Provided any therapeutic drug treatment for current episode of otitis media within the previous 14 days.
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 |
|---|---|---|
| Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension | Drug | Test |
| CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) | Drug | Reference |
| Placebo Sterile Otic Suspension | Drug | Placebo |
Primary outcome
Clinical Success
Time frame: Day 14-21
A patient who is considered a "clinical success" at Visit 4 (Test of Cure/End of Study) will have no signs or symptoms of active AOMT that were present at baseline nor any new signs or symptoms of AOMT have developed
1 secondary outcome
Cessation of Otorrhea
Time frame: Day 14-21
Results and safety
The study was stopped early (reason given: FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
Related trials for Otitis Media in Patients With Tympanostomy Tubes
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
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.
Chandra Vattikonda, Ph.D. study director
Par Pharamceutical, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension and CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) in people with Otitis Media in Patients With Tympanostomy Tubes, run by Par Pharmaceutical, Inc. at 23 sites in United States.
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 7 inclusion and 21 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: stopped early, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: Day 14-21). 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 2017.