Otitis ExternaPhase 2Ciprodexa FoamNCT01359098
Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
A Phase 2 study testing Ciprodex Otic Suspension and Ciprodexa Otic Foam in people with Otitis Externa and Otorhinolaryngologic Diseases, run by Otic Pharma at 7 sites in Israel.
Trial summary
The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases
- What is being tested?
- Ciprodex Otic Suspension and Ciprodexa Otic Foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesIsrael
- Study dates
- Jul 2011to Nov 2011
- Phase
- Phase 2
- 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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 3 years to 80 years old.
- Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- Intact tympanic membrane
- Unilateral disease
Who cannot join
- Known allergy or sensitivity to Ciprofloxacin or other quinolones.
- Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
- Patient has the non intact tympanic membrane.
- Patient has a serious underlying disease.
- Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
- Patients with history of Diabetes mellitus.
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- Patients with more than 80% of the ear canal occluded.
- Pregnant or lactating patients.
- Overt fungal Acute Otitis Externa.
- Local ear canal abnormalities such as abscess, granulation or polyps.
- Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
- Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
- Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
- Current Infection requiring systemic antimicrobial therapy.
- Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
HaEmek Medical Center
Afula
Soroka Medical Center
Beersheba
Wolfson Medical Center
Holon, 58100
Meir Medical Center
Kfar Saba, Israel
Clalit Health Services - Raziel Clinic
Netanya
Maccabi Healthcare Services (H.M.O.)
Tel Aviv
Sourasky Medical Center (Ichilov)
Tel Aviv
About this study
Official title: Safety and Efficacy of Once-Daily Dosing of Ciprodexa Otic Foam (Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Foam) Compared to Twice-Daily Dosing of Ciprodex (0.3% Ciprofloxacin and Dexamethasone 0.1% Otic Suspension) in Patients With Acute Otitis Externa
The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
Read the detailed description
Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge (otorrhea).
- Conditions
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis
- Being tested
- Ciprodex Otic Suspension, Ciprodexa Otic Foam
- Keywords
- swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation
- Medical subject headings
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis, Earache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprodex Otic SuspensionDrug
Also called Ciprodex, Ciprodex b.i.d.
4 gtt b.i.d. for 7 days.
Ciprodexa Otic FoamDrug
Also called Ciprofloxacin, Dexamethasone Otic Foam, Ciprodexa foam once-a-day
0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Ciprodex Otic Suspension | Active comparator | Ciprodex Sterile Otic Solution (Alcon, Inc.) Receives: Drug: Ciprodex Otic Suspension |
| Ciprodexa Otic Foam | Experimental | Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam) Receives: Drug: Ciprodexa Otic Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure [lack of need of additional therapy]
Clinical cure [lack of need of additional therapy] confirmed by significant reduction or absence of the disease symptoms a) Otalgia/ear pain, b) tenderness with movement of pinna, c) edema/ear canal occlusion and d) ear discharge/otorrhea
Measured: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days
Secondary outcomes (4)
Otalgia/ear pain
Ear pain as reported by the patient
Measured: At Visit 1, [Day 1 ,Baseline visit], at Visit 2 [Day 3 - Day 4, during treatment] and at Visit 3 Test-of-cure [Day 8 to Day 14]
Inflammation/ear edema
Measured: At the test-of-cure visit [Day 8 to Day 14]
Ear discharge/otorrhea
Measured: At the test-of-cure visit [Day 8 to Day 14]
tenderness with movement of pinna
Measured: At the test-of-cure visit [Day 8 - Day 14]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionNov 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otic Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yehudah Roth, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359098
- Sponsor's protocol ID
- OP-003-000
- Acronym
- Ciprodexa Foam
- Status last verified
- Nov 2011
- First submitted
- 20 May 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Once-Daily Dosing of Ciprodexa Otic Foam (Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Foam) Compared to Twice-Daily Dosing of Ciprodex (0.3% Ciprofloxacin and Dexamethasone 0.1% Otic Suspension) in Patients With Acute Otitis Externa
- ClinicalTrials.gov ID
- NCT01359098
- Acronym / sponsor ID
- Ciprodexa Foam / OP-003-000
- Conditions
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis
- Keywords
- swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Otic PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 May 2011 (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 purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
Detailed description
Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge (otorrhea).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprodex Otic Suspension | Active comparator | Drug: Ciprodex Otic SuspensionCiprodex Sterile Otic Solution (Alcon, Inc.) |
| Ciprodexa Otic Foam | Experimental | Drug: Ciprodexa Otic FoamCiprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam) |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 3 years to 80 years old.
- Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- Intact tympanic membrane
- Unilateral disease
Key exclusion criteria (16 listed)
- Known allergy or sensitivity to Ciprofloxacin or other quinolones.
- Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
- Patient has the non intact tympanic membrane.
- Patient has a serious underlying disease.
- Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
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 |
|---|---|---|
| Ciprodex Otic SuspensionAlso: Ciprodex, Ciprodex b.i.d.4 gtt b.i.d. for 7 days. | Drug | Ciprodex Otic Suspension |
| Ciprodexa Otic FoamAlso: Ciprofloxacin, Dexamethasone Otic Foam, Ciprodexa foam once-a-day0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days | Drug | Ciprodexa Otic Foam |
Primary outcome
Clinical cure [lack of need of additional therapy]
Time frame: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days
Clinical cure [lack of need of additional therapy] confirmed by significant reduction or absence of the disease symptoms a) Otalgia/ear pain, b) tenderness with movement of pinna, c) edema/ear canal occlusion and d) ear discharge/otorrhea
4 secondary outcomes
Otalgia/ear pain
Time frame: At Visit 1, [Day 1 ,Baseline visit], at Visit 2 [Day 3 - Day 4, during treatment] and at Visit 3 Test-of-cure [Day 8 to Day 14]
Inflammation/ear edema
Time frame: At the test-of-cure visit [Day 8 to Day 14]
Ear discharge/otorrhea
Time frame: At the test-of-cure visit [Day 8 to Day 14]
tenderness with movement of pinna
Time frame: At the test-of-cure visit [Day 8 - Day 14]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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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.
Yehudah Roth, MD principal investigator
Edith Wolfson Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciprodex Otic Suspension and Ciprodexa Otic Foam in people with Otitis Externa and Otorhinolaryngologic Diseases, run by Otic Pharma at 7 sites in Israel.
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 16 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: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cure [lack of need of additional therapy] (time frame: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days). 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 2 Nov 2011.