A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Ex… (NCT01910155) | Clinical Trial Compass
TerminatedPhase 3
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
Stopped: FDA's draft guidance (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence.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.
United States455 participantsStarted 2013-07
Plain-language 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) in the treatment of acute bacterial otitis externa.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. 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).
✕. 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