A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With… (NCT04305184) | Clinical Trial Compass
TerminatedPhase 1/2
A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)
Stopped: Lack of Efficacy
United States36 participantsStarted 2020-09-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion Criteria:
* Subject has one of following conditions that may affect the ipsilateral side of the ear with c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in SAD
Timeframe: From first dose up to day 57
2
Number of Participants With AE of Special Interest as Cholesteatoma or Ear Neoplasm in SAD
Timeframe: From first dose up to day 57
3
Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in SAD
Timeframe: From first dose up to day 57
4
Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in SAD
Timeframe: From first dose up to day 57
5
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 8/EOS in SAD