DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

Information source: Otic Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Intervention: Ciprodex Otic Suspension (Drug); Ciprodexa Otic Foam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Otic Pharma

Official(s) and/or principal investigator(s):
Yehudah Roth, MD, Principal Investigator, Affiliation: Edith Wolfson Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical cure [lack of need of additional therapy]

Secondary outcome:

Otalgia/ear pain

Inflammation/ear edema

Ear discharge/otorrhea

tenderness with movement of pinna

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

Minimum age: 3 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

HaEmek Medical Center, Afula, Israel

Soroka Medical Center, Beer Sheva, Israel

Wolfson Medical Center, Holon 58100, Israel

Meir Medical Center, Kfar Saba, Israel

Clalit Health Services - Raziel Clinic, Natania, Israel

Maccabi Healthcare Services (H.M.O.), Tel Aviv, Israel

Sourasky Medical Center (Ichilov), Tel Aviv, Israel

Additional Information

Starting date: July 2011
Last updated: November 1, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017