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Terminated/Withdrawn
Astellas Study ID
0598-CL-0101

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

Astellas Study ID
0598-CL-0101
Clinicaltrials.gov ID
NCT04305184
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The primary purpose of this study was to evaluate the safety and tolerability of ASP0598 Otic Solution. This study also evaluated the efficacy of ASP0598 otic solution.

Additional Study Details

Phase
Phase 1/Phase 2
Product
ASP0598
Product
ASP0598
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
36
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Download Document(s)
Plain Language Summary
Available Language(s): English
Download Document(s)
Protocol
Available Language(s): English
Download Document(s)
Statistical Analysis Plan (SAP)
Available Language(s): English
Download Document(s)

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)? Contact us by filling out your information to the right and we’ll respond to you.

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  • A healthcare provider
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  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
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  • Iceland
  • India
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  • Ireland
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  • Netherlands
  • New Zealand
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  • Peru
  • Philippines
  • Poland
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  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

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    Terminated
    Advanced ENT
    Louisville, Kentucky, United States, 40220
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    Withdrawn
    Omaha ENT
    Omaha, Nebraska, United States, 68118
    Contact Us
    Terminated
    Advanced ENT
    New Albany, Indiana, United States, 47150
    Contact Us
    Withdrawn
    Colorado ENT & Allergy
    Colorado Springs, Colorado, United States, 80909
    Contact Us
    Withdrawn
    University of Chicago
    Chicago, IL, United States, 60637
    Contact Us
    Withdrawn
    Columbia University Medical Center
    New York, NY, United States, 10032
    Contact Us
    Withdrawn
    University of Texas
    Dallas, TX, United States, 75235
    Contact Us
    Terminated
    Breathe Clear Institute
    Torrance, CA, United States, 90503
    Contact Us
    Terminated
    Piedmont ENT
    Winston-Salem, NC, United States, 27103
    Contact Us
    Withdrawn
    Ear Research Foundation
    Sarasota, FL, United States, 34329
    Contact Us
    Completed
    Charlotte ENT Associates
    Matthews, North Carolina, United States, 28105
    Contact Us
    Terminated
    ENT and Allergy Associates of Florida
    Boca Raton, Florida, United States, 33487
    Contact Us
    Withdrawn
    Central California ENT
    Fresno, California, United States, 93720
    Contact Us
    Terminated
    Richmond ENT
    Richmond, Virginia, United States, 23235
    Contact Us
    Withdrawn
    George Washington University
    Washington, District of Columbia, United States, 20037
    Contact Us
    Withdrawn
    Alamo ENT
    San Antonio, Texas, United States, 78258
    Contact Us
    Terminated
    Carolina ENT Clinic
    Orangeburg, South Carolina, United States, 29118
    Contact Us
    Withdrawn
    University of Arkansas
    Little Rock, Arkansas, United States, 72205
    Contact Us
    Terminated
    University of Michigan
    Ann Arbor, Michigan, United States, 48109
    Contact Us
    Withdrawn
    Tufts Medical Center
    Boston, Massachusetts, United States, 02111
    Contact Us
    Terminated
    Stanford Hospital
    Palo Alto, California, United States, 94304
    Contact Us
    Trial info
    Follow Trial
    Age
    18 - 75 Years
    Diamond icon
    Condition
  • Eardrum Perforation (Rupture)
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Sep 2020 - Jan 2023
    Additional Study Details
    Inclusion Criteria
    • Subject has chronic tympanic membrane perforation (CTMP) documented as persisting longer than 3 months.
    • A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
      • Not a woman of childbearing potential (WOCBP) OR
      • WOCBP who agrees to follow the contraceptive guidance starting at screening and for at least 28 days after investigational product (IP) application.
    • Female subject must agree not to breastfeed starting at drug application on Day 1 and for at least 28 days after IP application.
    • Female subject must not donate ova starting on Day 1 and for at least 28 days after investigational product (IP) application.
    • A male subject with female partner(s) of child-bearing potential must agree to use contraception starting on Day 1 and for at least 28 days after IP application.
    • A male subject must not donate sperm starting on Day 1 and for at least 28 days after IP application.
    • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom from Day 1 and for at least 28 days after IP application.
    • Subject must be willing and able to comply with the study requirements including refraining from using prohibited concomitant medications.
    • Subject agrees not to participate in another interventional study during the study period.
    MaximizeExclusion Criteria
    • Subject has one of following conditions that may affect the ipsilateral side of the ear with chronic tympanic membrane perforation (CTMP):
      • Perforation involving 3 or more quadrants.
      • Pin hole perforation (only for the expansion cohort).
      • Presence of tympanosclerosis adjacent to the perforation.
      • Perforation involves malleus erosion.
      • Absent malleus.
      • Marginal perforation (i.e., involving the annulus or exposing the handle of malleus).
      • Tympanic membrane perforation (TMP) caused by electric/slag/blast/burn injury.
      • Post radiated TMP.
      • History of tympanic membrane repair by any type of live tissue.
      • Active otorrhea or active treatment for otorrhea within the last 3 months prior to Screening.
      • Bellucci otorrhea grade 3 or above.
      • Active external ear canal inflammation (otitis externa, dermatitis) or within the last 3 months prior to Screening.
      • Active diagnosis of Eustachian Tube dysfunction or diagnosis within 6 months prior to Screening.
      • Craniofacial abnormalities, History of head and neck surgery within the last 3 months prior to Screening, history of radiation to head and neck.
      • Recent (within 2 weeks) diagnosis of upper respiratory tract infection.
      • Presence or history of cholesteatoma.
      • Presence of pars-flaccida or pars tensa retraction or adhesion.
      • Presence or history of tumors of the middle or external ear.
      • Contraindications to tympanic membrane closure.
      • An audiometric finding indicates a characteristic of Carhart's notch which is an increase in bone conduction threshold with a peak at 2,000 hertz (Hz).
      • Only hearing ear or better hearing ear and the contralateral ear ≥ 40 dB (decibels) by average four-frequency (500, 1000, 2000 and 4000 Hz).
      • Whole circumference of the tympanic membrane perforation is not visible by endoscope.
      • Presence/history of eosinophilic otitis media in either ear.
    • Subject has a presence of adhesive otitis media in the contralateral ear.
    • Subject has a presence of any wound healing systemic condition.
    • Subject has Obstructive Sleep Apnea where the subject is required to use Continuous Positive Airway Pressure (CPAP) during the study period.
    • Subject is exposed in their daily life to high volume of water into the ear canal (e.g., swimmer or surfer).
    • Subject has health conditions that would prevent him/her from fulfilling the study requirements on the basis of medical history and laboratory test (Serum Chemistries, complete blood count [CBC] with Differential, Urinalysis) results at the screening visit.
    • Subject is receiving any other investigational agents during study participation.
    • Subject has any form of substance abuse, or psychiatric illness/social situations that would limit compliance with study requirements, or a condition that could invalidate communication.
    • Subject has a known or suspected hypersensitivity to ASP0598, or any components of the formulation used.
    • Subject has had previous exposure with ASP0598.
    • Subject is unlikely to comply with the visits scheduled in the protocol.

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