Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa (Ciprodexa Foam)
This study has been completed.
Sponsor:
Otic Pharma
Information provided by (Responsible Party):
Otic Pharma
ClinicalTrials.gov Identifier:
NCT01359098
First received: May 20, 2011
Last updated: November 1, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis |
Drug: Ciprodex Otic Suspension Drug: Ciprodexa Otic Foam |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Ear Disorders
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Ciprofloxacin
Ciprofloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Otic Pharma:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- 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] ] [ Designated as safety issue: No ]Ear pain as reported by the patient
- Inflammation/ear edema [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ] [ Designated as safety issue: No ]
- Ear discharge/otorrhea [ Time Frame: At the test-of-cure visit [Day 8 to Day 14] ] [ Designated as safety issue: No ]
- tenderness with movement of pinna [ Time Frame: At the test-of-cure visit [Day 8 - Day 14] ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ciprodex Otic Suspension
Ciprodex Sterile Otic Solution (Alcon, Inc.)
|
Drug: Ciprodex Otic Suspension
4 gtt b.i.d. for 7 days.
Other Names:
|
|
Experimental: Ciprodexa Otic Foam
Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)
|
Drug: Ciprodexa Otic Foam
0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 3 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359098
Locations
| Israel | |
| HaEmek Medical Center | |
| Afula, Israel | |
| Soroka Medical Center | |
| Beer Sheva, Israel | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
| Meir Medical Center | |
| Kfar Saba, Israel | |
| Clalit Health Services - Raziel Clinic | |
| Natania, Israel | |
| Sourasky Medical Center (Ichilov) | |
| Tel Aviv, Israel | |
| Maccabi Healthcare Services (H.M.O.) | |
| Tel Aviv, Israel | |
Sponsors and Collaborators
Otic Pharma
Investigators
| Principal Investigator: | Yehudah Roth, MD | Edith Wolfson Medical Center |
More Information
No publications provided
| Responsible Party: | Otic Pharma |
| ClinicalTrials.gov Identifier: | NCT01359098 History of Changes |
| Other Study ID Numbers: | OP-003-000 |
| Study First Received: | May 20, 2011 |
| Last Updated: | November 1, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Otic Pharma:
|
swimmer's ear ear drops ear foam otic foam |
ear infection ear pain ear inflammation |
Additional relevant MeSH terms:
|
Ear Diseases Otitis Externa Otitis Otorhinolaryngologic Diseases Ciprofloxacin BB 1101 Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents |
Therapeutic Uses Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013