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ASP0598 for Perforated Eardrum

Phase 1 & 2

Waitlist Available

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose up to day 85

Awards & highlights

Study Summary

This trial is testing a new ear drop to see if it is safe and effective.

Eligible Conditions

Chronic Perforated Eardrum

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose up to day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose up to day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 12/EOS in MAD

Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 8/EOS in SAD

Change From Baseline in TVAS at Week 12/EOS in MAD

+9 more

Secondary outcome measures

Change From Baseline in TMP Size at Week 12 for Dose Expansion

Change From Baseline in TMP Size at Week 12 for MAD

Change From Baseline in TMP Size at Week 16 for Dose Expansion

+9 more

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Single Ascending Dose (SAD): 0.03 mcgExperimental Treatment1 Intervention

Participants received single dose of 0.03 microgram (mcg) ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 [End of Study (EOS)].

Group II: SAD: 2.25 mcgExperimental Treatment1 Intervention

Participants received single dose of 2.25 mcg ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group III: SAD: 0.75 mcgExperimental Treatment1 Intervention

Participants received single dose of 0.75 mcg ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group IV: SAD: 0.15 mcgExperimental Treatment1 Intervention

Participants received single dose of 0.15 mcg ASP0598 Otic Solution into the affected ear on Day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group V: Multiple Ascending Dose (MAD): 0.75 mcgExperimental Treatment1 Intervention

Participants received multiple doses of 0.75 mcg ASP0598 Otic Solution into the affected ear on days 1, 15 and 29 and returned to the investigative site for assessments on days 8, 15, 22, 29, 36, 57, and 85 (EOS).

Group VI: MAD: 2.25 mcgExperimental Treatment1 Intervention

Participants received multiple doses of 2.25 mcg ASP0598 Otic Solution into the affected ear on days 1, 15 and 29 and returned to the investigative site for assessments on days 8, 15, 22, 29, 36, 57, and 85 (EOS).

Group VII: SAD: PlaceboPlacebo Group1 Intervention

Participants received single dose of placebo matched to ASP0598 Otic Solution into the affected ear on day 1 and returned to the investigative site for assessments on days 2, 3, 8, 15, 29, and 57 (EOS).

Group VIII: MAD: PlaceboPlacebo Group1 Intervention

Participants received multiple doses of placebo matched to ASP0598 Otic Solution into the affected ear on days 1, 15 and 29 and returned to the investigative site for assessments on days 8, 15, 22, 29, 36, 57, and 85 (EOS).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

121,026 Total Patients Enrolled

Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.

2,777 Previous Clinical Trials

8,063,444 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be satisfied for an individual to qualify for this research program?

"Eligibility criteria for this trial necessitates tympanic membrane perforation and a patient age between 18-75. Currently, the medical team is recruiting 114 patients in total."

Answered by AI

What is the participant intake for this experiment?

"Astellas Pharma Global Development, Inc. are in need of 114 qualified patients for their medical trial conducted at Richmond ENT and George Washington University located in the Virginia-District of Columbia metropolitan area."

Answered by AI

In what regions of the United States is this clinical research being conducted?

"This trial is recruiting from a plethora of medical sites, such as Richmond ENT in Virginia, George Washington University in D.C., and Columbia University Medical Center in New york City. Altogether there are 13 other recruitment locations involved with this study."

Answered by AI

Are participants of all ages being considered for this scientific inquiry?

"This medical trial is only accepting patients aged 18-75. Those younger than the requirement can participate in 1 dedicated clinical trial, while those older are eligible for 4 separate studies."

Answered by AI

Are there still patient openings for this research endeavor?

"That is accurate. According to clinicaltrials.gov, this medical study was initially posted on September 10th 2020 and has been actively recruiting since then. The researchers are seeking 114 individuals from 13 trial sites for the project's execution."

Answered by AI

What is the ultimate ambition of this medical experiment?

"The objective of this research study, which will be evaluated between the Baseline and Day 113 markpoints, is to catalogue any adverse events that occur in the MAD cohort. Secondary data objectives include measuring changes in TMP size relative to tympanic membrane area over a single dose expansion period as well as determining proportion of patients with complete closure of their TMPs during said dosing schedule."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04305184.