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NCT04305184 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Astellas Pharma Global Development.

Terminated
Registry status
Phase 1
Development phase
36
Enrollment target

NCT04305184: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.

NCT04305184 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04305184, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.

TERMINATED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

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.

Primary Outcome

An adverse event (AE) is any untoward medical occurrence in a participant administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A TEAE is defined as an AE observed after starting administration of the study drug through end of study visit.

Interventions

  • OTHER Placebo
  • DRUG ASP0598

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2020-09-10
Est. Completion 2023-01-24
Phase Phase 1
Astellas Pharma Global Development

168 total trials

Why NCT04305184 stopped before completion

NCT04305184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04305184 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04305184 about?

NCT04305184 is a clinical study titled "A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)". 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.

What is the current status of trial NCT04305184?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-09-10. Estimated completion is 2023-01-24.

What interventions are being tested in trial NCT04305184?

The interventions under investigation include: Placebo (OTHER), ASP0598 (DRUG).

Who is sponsoring clinical trial NCT04305184?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04305184's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04305184, the US trial registry maintained by the National Library of Medicine. NCT04305184 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.