Otitis ExternaPhase 3NCT01910155
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
A Phase 3 study testing Ciprofloxacin/Dexamethasone and Ciprodex (R) in people with Otitis Externa, run by Par Pharmaceutical, Inc. at 32 sites in 2 countries.
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 Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Otitis Externa
- What is being tested?
- Ciprofloxacin/Dexamethasone and Ciprodex (R)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non lactating females 18-65 years of age inclusive.
- Signed informed consent form, which meets all of the criteria of current FDA regulations.
- If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, injected, transdermal or implanted hormonal contraceptives). Patients on hormonal contraceptives must have been on the same method/type for at least 28 days prior to the start of the study and remain on the same throughout the study.
- The presence of infection confirmed by a positive bacterial culture for the presence of Pseudomonas aeruginosa or Staphylococcus aureus. 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.
- Clinical signs and symptoms consistent with bacterial otitis externa as defined by a combined Total Symptom Score (TSS) of at least 6 with a score of least 2 for otalgia using the following scale 0=none, 1=mild, 2=moderate, 3=severe.
Who cannot join
- Females who are pregnant, breast feeding, or anticipate becoming pregnant during the study.
- Signs and symptoms of otitis externa for longer than 21 days prior to being screened for inclusion in the study.
- Previous episode of otitis externa within the previous 6 months or more than 2 episodes within the previous 12 months.
- Been provided any therapeutic drug treatment for current episode of otitis externa.
- Known history of, or ear exam reveals tympanic membrane perforation or damage for any reason.
- Current or previous history of any otologic surgery including 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 externa e.g. chronic suppurative otitis externa, acute otitis media
- 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.
- 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 28 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 2 weeks 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.
- Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
- 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
32 sites in 2 countries.
32 sites in 2 countries
United States27 sites
Gilbert Ledesma, MD
Arlington, Texas, 76012
Integrated Medical Research PC
Ashland, Oregon, 97520
Pioneer Clinical Research
Bellevue, Nebraska, 68005
ENT of South Florida
Boyton Beach, Florida, 33426
Monica Davis, MD
Brentwood, Tennessee, 37027
John Champlin, MD
Carmichael, California, 95608
Julia Mullen, MD
Cincinnati, Ohio, 45246
Moore Clinical Research Inc
Fort Myers, Florida, 33919
Cyn3rgy
Gresham, Oregon, 97030
Jorge Diaz, MD
Hialeah, Florida, 33016
West Houston Clinical Research Service
Houston, Texas, 77055
Nea Baptist Clinic
Jonesboro, Arkansas, 72401
R-D Clinical Research
Lake Jackson, Texas, 77566
Applied Reserch Center
Little Rock, Arkansas, 72212
Aliance Research
Long Beach, California, 90813
The Education and Research Foundation Inc.
Lynchburg, Virginia, 24501
San Marcus Research Clinic
Miami, Florida, 33015
The Medical Consulting Center
Miami, Florida, 33125
John Ansley, MD
Orangeburg, South Carolina, 29118
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Research Integrity, LLC
Owensboro, Kentucky, 42303
PMG Research of Raleigh
Raleigh, North Carolina, 27609
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Spartanburg and Geer ENT
Spartanburg, South Carolina, 29303
James Donivan Gordon, MD
Tucson, Arizona, 85745
Peak Research LLC
Upper Saint Clair, Pennsylvania, 15241
Winter Park Clinical Research
Winter Park, Florida, 32792
Puerto Rico5 sites
SMO The Clinical Research Group
Canovanas, PR, 00729
Clinical Research Puerto Rico Guayama
Levittown, PR, 00949
SMO The Clinical Research Group
Naranjito, PR, 00719
SMO The Clinical Research Group
San Juan, PR, 00917
SMO The Clinical Resarch Group
Santa Isabel, PR, 00757
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 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 Adults With Acute Bacterial Otitis Externa
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 Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
- Conditions
- Otitis Externa
- Being tested
- Ciprofloxacin/Dexamethasone, Ciprodex (R), Placebo
- Medical subject headings
- Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin/DexamethasoneDrug
Ciprodex (R)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Ciprofloxacin/Dexamethasone Receives: Drug: Ciprofloxacin/Dexamethasone |
| Reference | Active comparator | Ciprodex (R) Receives: Drug: Ciprodex (R) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit
Measured: Day 14-21
Secondary outcomes (1)
Resolution of Symptoms
The time to complete resolution of disease specific clinically meaningful signs and symptoms at enrollment and the absence of new symptoms
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 posted29 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionMar 2015
Why it stopped: FDA's draft guidance (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence. Small study size resulted in negative culture rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis ExternaStudies 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
- 455 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 S Vattikonda, Ph.D., Study director, Par Pharamceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910155
- Sponsor's protocol ID
- 71205502
- Status last verified
- Oct 2016
- First submitted
- 25 Jul 2013
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 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 Adults With Acute Bacterial Otitis Externa
- ClinicalTrials.gov ID
- NCT01910155
- Acronym / sponsor ID
- 71205502
- Conditions
- Otitis Externa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA's draft guidance (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence. Small study size resulted in negative culture rates.
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Jul 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jul 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 Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Ciprofloxacin/DexamethasoneCiprofloxacin/Dexamethasone |
| Reference | Active comparator | Drug: Ciprodex (R)Ciprodex (R) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant, non lactating females 18-65 years of age inclusive.
- Signed informed consent form, which meets all of the criteria of current FDA regulations.
- If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, injected, transdermal or implanted hormonal contraceptives). Patients on hormonal contraceptives must have been on the same method/type for at least 28 days prior to the start of the study and remain on the same throughout the study.
- The presence of infection confirmed by a positive bacterial culture for the presence of Pseudomonas aeruginosa or Staphylococcus aureus. 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.
- Clinical signs and symptoms consistent with bacterial otitis externa as defined by a combined Total Symptom Score (TSS) of at least 6 with a score of least 2 for otalgia using the following scale 0=none, 1=mild, 2=moderate, 3=severe.
Key exclusion criteria (21 listed)
- Females who are pregnant, breast feeding, or anticipate becoming pregnant during the study.
- Signs and symptoms of otitis externa for longer than 21 days prior to being screened for inclusion in the study.
- Previous episode of otitis externa within the previous 6 months or more than 2 episodes within the previous 12 months.
- Been provided any therapeutic drug treatment for current episode of otitis externa.
- Known history of, or ear exam reveals tympanic membrane perforation or damage for any reason.
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/Dexamethasone | Drug | Test |
| Ciprodex (R) | Drug | Reference |
| Placebo | Drug | Placebo |
Primary outcome
Clinical Success
Time frame: Day 14-21
Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit
1 secondary outcome
Resolution of Symptoms
Time frame: Day 14-21
Results and safety
The study was stopped early (reason given: FDA's draft guidance (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence. Small study size resulted in negative culture rates.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
Chandra S Vattikonda, Ph.D. study director
Par Pharamceutical, Inc.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin/Dexamethasone and Ciprodex (R) in people with Otitis Externa, run by Par Pharmaceutical, Inc. at 32 sites in 2 countries.
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 5 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Puerto Rico. 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 (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence. Small study size resulted in negative culture rates.). 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 18 Oct 2016.