OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).
Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or >2 years.
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
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California
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San Diego, California, Förenta staterna, 92121
- Call/email Otonomy Central Contact for Trial Locations
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female aged 6 months to 17 years, inclusive
- Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
- Subject's caregiver is willing to comply with the protocol and attend all study visits
Exclusion Criteria includes, but is not limited to:
- Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
- Subject has a history of sensorineural hearing loss
- Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: OTO-201
OTO-201: Enstaka intratympanisk injektion: En injektion av 6 mg OTO-201 (ciprofloxacin i poloxamer 407) i varje öra under operation. |
Enstaka intratympanisk injektion
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Sham Comparator: Bluff
Sham: Simulerad enkel intratympanisk injektion: En skeninjektion i varje öra under operationen. |
Simulerad enkel intratympanisk injektion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Who Were Treatment Failures
Tidsram: Day 15 - 2 weeks after dosing
|
Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up. |
Day 15 - 2 weeks after dosing
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry
Tidsram: Up to one month
|
Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.
|
Up to one month
|
|
Microbiological Response
Tidsram: Day 15 - 2 weeks after dosing
|
Subjects whose samples tested positive for bacteria in either or both ears.
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Day 15 - 2 weeks after dosing
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Carl LeBel, PhD, Otonomy, Inc.
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201-201302
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