Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
Information source: Otic Pharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
Intervention: 0.3% Ciprofloxacin Ear Drops (Drug); 0.3% Ciprofloxacin Foam Otic Cipro (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Otic Pharma Official(s) and/or principal investigator(s):
Yehudah Roth, MD, Principal Investigator, Affiliation: Edith Wolfson Medical Center
Overall contact:
Rodrigo A Yelin, PhD, Phone: +972 54 5960199, Email: rodrigo.yelin@oticpharma.com
Summary
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel
medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.
The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
Clinical Details
Official title: Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
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. The
reported annual incidence of AOE is between 1: 100 and 1: 250 in the general population with
large seasonal and regional variations. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Aged 18 and older eligible to sign by themselves.
- Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and
of presumed bacterial origin.
- Intact tympanic membrane
- Unilateral Acute Otitis Externa
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.
- Bilateral Acute Otitis Externa.
- 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
Rodrigo A Yelin, PhD, Phone: +972 54 5960199, Email: rodrigo.yelin@oticpharma.com
Wolfson Medical Center, Holon 58100, Israel; Recruiting
Yehudah Roth, MD, Phone: +972-3-5028651, Email: orl@wolfson.health.gov.il
Tal Marom, MD, Phone: +972 57 8170575, Email: maromtal@013.net.il
Yehudah Roth, MD, Principal Investigator
Marom Tal, MD, Sub-Investigator
Avi Goldfarb, MD, Sub-Investigator
Maxim Sokolov, MD, Sub-Investigator
Eyal Russo, MD, Sub-Investigator
Dalia Levi, MD, Sub-Investigator
Udi Cinamon, MD, Sub-Investigator
Haim Flaksman, MD, Sub-Investigator
Yahav Oron, MD, Sub-Investigator
Sagit Shushan, MD, Sub-Investigator
Inbal Weiss, MD, Sub-Investigator
Waseem Wated, MD, Sub-Investigator
Mazen Kazlak, MD, Sub-Investigator
HaEmek Medical Center, Afula, Israel; Recruiting
Yoseph Rakover, MD, Phone: +972 4 6494310 /1, Email: rakover@clalit.org.il
Lev Shlizerman, MD, Phone: +972 4 6494310 /1, Email: sagitsh@actcom.net.il
Yoseph Rakover, MD, Principal Investigator
Lev Shlizerman, MD, Sub-Investigator
Salim Mazzawi, MD, Sub-Investigator
Ella Even-Tov, MD, Sub-Investigator
Nely Goldenblum, MD, Sub-Investigator
Joseph Dib, MD, Sub-Investigator
Limor Benyamini, MD, Sub-Investigator
Yosef Segal, MD, Sub-Investigator
Tayser Bishara, MD, Sub-Investigator
Avi Wilder, MD, Sub-Investigator
Assaf Harofeh Medical Center, Zerifin 70300, Israel; Recruiting
Ephraim Eviatar, MD, Phone: +972-8-9779317, Email: eviatar@asaf.health.gov.il
Eyal Yehezkeli, MD, Phone: +972-57-7345344, Email: eyalye@clalit.org.il
Raya Cohen, MD, Sub-Investigator
Nathan Shlamkovitch, MD, Sub-Investigator
Daniel Krakovsky, MD, Sub-Investigator
Alex Pomortsev, MD, Sub-Investigator
Aviram Eliad, MD, Sub-Investigator
Zeev Eisen, MD, Sub-Investigator
Lior Joshua, MD, Sub-Investigator
Lia Sagi, MD, Sub-Investigator
Ephraim Eviatar, MD, Principal Investigator
Eyal Yehezkeli, MD, Sub-Investigator
Maccabi Healthcare Services, Tel Aviv 68125, Israel; Recruiting
Yehudah Roth, MD, Phone: +972-3-5028651, Email: orl@wolfson.health.gov.il
Abraham Goldfarb, MD, Email: avidoc_il@yahoo.com
Yehudah Roth, MD, Principal Investigator
Avi Goldfarb, MD, Sub-Investigator
Maxim Sokolov, MD, Sub-Investigator
Eyal Russo, MD, Sub-Investigator
Dalia Levi, MD, Sub-Investigator
Udi Cinamon, MD, Sub-Investigator
Haim Flaksman, MD, Sub-Investigator
Yahav Oron, MD, Sub-Investigator
Additional Information
Starting date: May 2009
Ending date: October 2009
Last updated: September 14, 2009
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