- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01949142
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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California
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San Diego, California, Forenede Stater, 92121
- Call/email Otonomy Central Contact for Trial Locations
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: OTO-201
OTO-201: Enkelt, intratympanisk injektion: En injektion på 6 mg OTO-201 (ciprofloxacin i poloxamer 407) i hvert øre under operationen. |
Enkelt, intratympanisk injektion
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Sham-komparator: Falsk
Sham: Simuleret enkelt, intratympanisk injektion: En falsk injektion i hvert øre under operationen. |
Simuleret enkelt, intratympanisk injektion
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Who Were Treatment Failures
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry
Tidsramme: Up to one month
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Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.
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Up to one month
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Microbiological Response
Tidsramme: Day 15 - 2 weeks after dosing
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Subjects whose samples tested positive for bacteria in either or both ears.
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Day 15 - 2 weeks after dosing
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Carl LeBel, PhD, Otonomy, Inc.
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201-201302
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Bezmialem Vakif UniversityAfsluttet
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Lee's Pharmaceutical LimitedUkendtKronisk Suppurativ Otitis MediaKina
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Nationwide Children's HospitalTrukket tilbageMellemørebetændelse med effusion (OME)
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Boston Medical CenterTrukket tilbageMellemørebetændelse med effusion hos børn | OtorrheaForenede Stater
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Eye & ENT Hospital of Fudan UniversityChildren's Hospital of Fudan University; Xinhua Hospital, Shanghai Jiao...Ikke rekrutterer endnuMellemørebetændelse med effusion hos børn
Kliniske forsøg med OTO-201
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Otonomy, Inc.AfsluttetAkut mellemørebetændelse | AOMTForenede Stater
-
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-
Otonomy, Inc.AfsluttetMellemørebetændelse med effusionForenede Stater
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Otonomy, Inc.AfsluttetSubjektiv tinnitusForenede Stater, Det Forenede Kongerige, Tyskland, Polen
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Regeneron PharmaceuticalsRekrutteringMedfødt høretab sekundært til bialleliske mutationer af Otoferlin-genet (OTOF)Spanien, Det Forenede Kongerige, Forenede Stater
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Otonomy, Inc.Afsluttet
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Emory UniversityChildren's Healthcare of Atlanta; Georgia Institute of TechnologyAfsluttetAkut otitis ekstern | Akut mellemørebetændelseForenede Stater