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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Tympanic Membrane Perforation

In brief

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.

Key facts

Study ID

NCT04305184

Run by

Astellas Pharma Global Development, Inc.

People needed

36

Starts

2020-09-10

Expected to finish

2023-01-24

Last updated by the study team

2024-11-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford Hospital — Palo Alto, California, United States
• Breathe Clear Institute — Torrance, California, United States
• ENT and Allergy Associates of Florida — Boca Raton, Florida, United States
• Advanced ENT — New Albany, Indiana, United States
• Advanced ENT — Louisville, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Charlotte ENT Associates — Matthews, North Carolina, United States
• Piedmont ENT — Winston-Salem, North Carolina, United States
• Carolina ENT Clinic — Orangeburg, South Carolina, United States
• Richmond ENT — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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