A Phase 1/2 interventional study of ASP0598 and Placebo in Chronic Tympanic Membrane Perforation, sponsored by Astellas Pharma Global Development, Inc.. Terminated at 10 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Astellas Pharma Global Development, Inc. · Phase 1/2, Interventional, and Treatment
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.
This study consisted of a dose escalation (single ascending dose - SAD and multiple ascending dose- MAD) and dose expansion (single dose expansion and/or multiple dose expansion). Dose escalation consisted of up to 4 cohorts for single ascending dose (SAD) and up to 2 cohorts for multiple ascending dose (MAD) with different dose levels. For SAD, after randomization on Day 1, participants received ASP0598 Otic Solution or placebo administration into the affected ear. Participants returned to the site on days 2, 3, 8, 15, 29, and 57 [end of study (EOS)]. Day 3 evaluations were only performed for cohorts 1, 2 and 3. For MAD, after randomization on Day 1, participants received ASP0598 Otic Solution or placebo administration into the affected ear and received additional treatments into the same ear on Days 15 and 29. Participants returned to the investigative site on Days 8, 15, 22, 29, 36, 57, and 85 (EOS). Dose expansion was based on the safety and efficacy results from an interim analysis. An interim analysis was conducted after completion of SAD and again after completion of MAD. The single and multiple dose expansion parts of the study were not opened following review of safety and efficacy results of SAD and MAD parts of the study by the DMC per the Interim Analysis Plan.
45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.
This study's enrollment of 36 is below the median of 57 across 31 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
Exclusion Criteria:
Subject has one of following conditions that may affect the ipsilateral side of the ear with chronic tympanic membrane perforation (CTMP):
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 \[End of Study (EOS)\].
Drug: ASP0598
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).
Drug: ASP0598
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).
Drug: ASP0598
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).
Drug: ASP0598
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).
Other: Placebo
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).
Drug: ASP0598
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).
Drug: ASP0598
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).
Other: Placebo
ASP0598 Otic solution was administered onto the Tympanic Membrane (TM) through the external auditory canal via syringe.
Placebo matched to ASP0598 Otic solution was administered onto the TM through the external auditory canal via syringe.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in SAD
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.
Time frame: From first dose up to day 57
Number of Participants With AE of Special Interest as Cholesteatoma or Ear Neoplasm in SAD
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with cholesteatoma or ear neoplasm is reported.
Time frame: From first dose up to day 57
Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in SAD
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with any ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) is reported.
Time frame: From first dose up to day 57
Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in SAD
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with otitis media or otitis externa is reported.
Time frame: From first dose up to day 57
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 8/EOS in SAD
PTA was a behavioral and quantitative hearing test to assess hearing. Pure tone air conduction and bone conduction tests were used to determine whether there was any unilateral or bilateral hearing loss, what type of hearing loss was present, which frequencies were impacted, and the magnitude of the hearing loss.
Time frame: Baseline and week 8
Change From Baseline in TVAS at Week 8/EOS in SAD
TVAS was used by participants to rate their tinnitus at baseline and week 8. The scale was a numeric scale and ranged from 0 (not at all strong or loud) to 10 (extremely strong or loud). A lower value indicates less level of discomfort. For the change from baseline, a negative value indicates improvement (less level of discomfort).
Time frame: Baseline and week 8
Number of Participants With TEAEs in MAD
An AE is any untoward medical occurrence in a participant administered an 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.
Time frame: From first dose up to day 85
Number of Participants With AE Special Interest as Cholesteatoma or Ear Neoplasm in MAD
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with cholesteatoma or ear neoplasm is reported.
Time frame: From first dose up to day 85
Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in MAD
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with any Ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) is reported
Time frame: From first dose up to day 85
Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in MAD
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with otitis media or otitis externa is reported.
Time frame: From first dose up to day 85
Change From Baseline in Bone Conduction Hearing at 1, 2, 4 kHz by Pure Tone Audiometry at Week 12/EOS in MAD
PTA was a behavioral and quantitative hearing test to assess hearing. Pure tone air conduction and bone conduction tests were used to determine whether there was any unilateral or bilateral hearing loss, what type of hearing loss was present, which frequencies were impacted, and the magnitude of the hearing loss.
Time frame: Baseline and week 12
Change From Baseline in TVAS at Week 12/EOS in MAD
TVAS was used by participants to rate their tinnitus at baseline and week 12. The scale was a numeric scale and ranged from 0 (not at all strong or loud) to 10 (extremely strong or loud). A lower value indicates less level of discomfort. For the change from baseline, a negative value indicates improvement (less level of discomfort).
Time frame: Baseline and week 12
Number of Participants With Complete Closure of Tympanic Membrane Perforation (TMP) at Week 8 for SAD
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
Time frame: Week 8
Number of Participants With Complete Closure of TMP at Week 12 for Dose Expansion
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
Time frame: Week 12
Change From Baseline in the Ratio of TMP Size Per Total Area of Tympanic Membrane at Week 8 for SAD
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and measured in percentage.
Time frame: Baseline and week 8
Change From Baseline in the Ratio of TMP Size Per Total Area of Tympanic Membrane at Week 12 for Dose Expansion
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and was measured by percentage.
Time frame: Baseline and week 12
Change From Baseline in TMP Size at Week 8 for SAD
TMP size calculation was be performed by central imaging vendor.
Time frame: Baseline and week 8
Change From Baseline in TMP Size at Week 12 for Dose Expansion
TMP size calculation was be performed by central imaging vendor.
Time frame: Baseline and week 12
Number of Participants With Complete Closure of TMP at Week 12 for MAD
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
Time frame: Week 12
Number of Participants With Complete Closure of TMP at Week 16 for Dose Expansion
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
Time frame: Week 16
Change From Baseline in the Ratio of TMP Size Per Total Area of Tympanic Membrane at Week 12 for MAD
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and measured in percentage.
Time frame: Baseline and week 12
Change From Baseline in the Ratio of TMP Size Per Total Area of Tympanic Membrane at Week 16 for Dose Expansion
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and measured in percentage.
Time frame: Baseline and week 16
Change From Baseline in TMP Size at Week 12 for MAD
TMP size calculation was be performed by central imaging vendor.
Time frame: Baseline and week 12
Change From Baseline in TMP Size at Week 16 for Dose Expansion
TMP size calculation was be performed by central imaging vendor.
Time frame: Baseline and week 16
Participants with Chronic Tympanic Membrane Perforation (CTMP) documented as persisting longer than 3 months were enrolled in this study.
| Milestone | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 0 | 0 | 0 |
| Completed | 4 | 4 | 4 | 4 | 4 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 6 | 6 | 4 |
| Completed | 0 | 0 | 0 | 0 | 0 | 6 | 6 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in SAD | 4 | 1 | 3 | 3 | 2 |
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with cholesteatoma or ear neoplasm is reported.
| Participants | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Number of Participants With AE of Special Interest as Cholesteatoma or Ear Neoplasm in SAD | 0 | 0 | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with any ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) is reported.
| Participants | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in SAD | 2 | 0 | 1 | 1 | 0 |
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with otitis media or otitis externa is reported.
| Participants | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in SAD | 1 | 0 | 0 | 1 | 0 |
PTA was a behavioral and quantitative hearing test to assess hearing. Pure tone air conduction and bone conduction tests were used to determine whether there was any unilateral or bilateral hearing loss, what type of hearing loss was present, which frequencies were impacted, and the magnitude of the hearing loss.
| decibles | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| 1 kHz | -1.3 ± 2.5 | 0.0 ± 4.1 | 0.0 ± 4.1 | -2.5 ± 6.5 | 1.3 ± 6.3 |
| 2 kHz | 1.3 ± 2.5 | -1.3 ± 2.5 | 2.5 ± 8.7 | -3.8 ± 8.5 | -1.3 ± 4.8 |
| 4 kHz | 0.0 ± 4.1 | -1.3 ± 4.8 | 1.3 ± 7.5 | -1.3 ± 4.8 | 0.0 ± 7.1 |
TVAS was used by participants to rate their tinnitus at baseline and week 8. The scale was a numeric scale and ranged from 0 (not at all strong or loud) to 10 (extremely strong or loud). A lower value indicates less level of discomfort. For the change from baseline, a negative value indicates improvement (less level of discomfort).
| Score on a scale | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Change From Baseline in TVAS at Week 8/EOS in SAD | -0.3 ± 0.5 | 0.0 ± 0.0 | -1.0 ± 2.0 | 0.3 ± 2.9 | -1.5 ± 2.4 |
An AE is any untoward medical occurrence in a participant administered an 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.
| Participants | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Number of Participants With TEAEs in MAD | 6 | 5 | 4 |
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with cholesteatoma or ear neoplasm is reported.
| Participants | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Number of Participants With AE Special Interest as Cholesteatoma or Ear Neoplasm in MAD | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with any Ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) is reported
| Participants | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Number of Participants With AE of Special Interest as Ototoxic Symptoms (Tinnitus, Sensorineural Hearing Loss, Dizziness) in MAD | 2 | 1 | 0 |
An AE is any untoward medical occurrence in a participant administered an 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. Number of participants with otitis media or otitis externa is reported.
| Participants | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Number of Participants With AE of Special Interest as Otitis Media or Otitis Externa in MAD | 1 | 0 | 0 |
PTA was a behavioral and quantitative hearing test to assess hearing. Pure tone air conduction and bone conduction tests were used to determine whether there was any unilateral or bilateral hearing loss, what type of hearing loss was present, which frequencies were impacted, and the magnitude of the hearing loss.
| decibles | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| 1 kHz | 1.0 ± 2.2 | -3.3 ± 6.1 | -1.7 ± 2.9 |
| 2 kHz | 1.0 ± 2.2 | -2.5 ± 5.2 | 0.0 ± 5.0 |
| 4 kHz | 2.0 ± 7.6 | -1.7 ± 6.8 | -6.7 ± 2.9 |
TVAS was used by participants to rate their tinnitus at baseline and week 12. The scale was a numeric scale and ranged from 0 (not at all strong or loud) to 10 (extremely strong or loud). A lower value indicates less level of discomfort. For the change from baseline, a negative value indicates improvement (less level of discomfort).
| Score on a scale | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Change From Baseline in TVAS at Week 12/EOS in MAD | -0.6 ± 1.3 | -0.7 ± 2.0 | 0.0 ± 2.0 |
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
| Participants | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Number of Participants With Complete Closure of Tympanic Membrane Perforation (TMP) at Week 8 for SAD | 0 | 0 | 1 | 0 | 0 |
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
No measurements were reported for this outcome.
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and measured in percentage.
| Percentage of total area of TM | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Change From Baseline in the Ratio of TMP Size Per Total Area of Tympanic Membrane at Week 8 for SAD | -0.4 ± 0.6 | 4.2 ± 6.3 | -1.8 ± 2.3 | 1.0 ± 0.5 | 0.3 ± 3.0 |
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and was measured by percentage.
No measurements were reported for this outcome.
TMP size calculation was be performed by central imaging vendor.
| mm^2 | SAD: 0.03 mcg | SAD: 0.15 mcg | SAD: 0.75 mcg | SAD: 2.25 mcg | SAD: Placebo |
|---|---|---|---|---|---|
| Change From Baseline in TMP Size at Week 8 for SAD | 13451.0 ± 9700.9 | 14271.5 ± 11800.6 | 9572.0 ± 9462.7 | 12784.3 ± 5277.9 | 27389.0 ± 37917.3 |
TMP size calculation was be performed by central imaging vendor.
No measurements were reported for this outcome.
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
| Participants | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Number of Participants With Complete Closure of TMP at Week 12 for MAD | 0 | 0 | 1 |
Tympanic membrane perforation is a hole in the thin membrane that separates the ear canal from the middle ear. TMP closure is defined as microscopic TMP closure without presence of pin hole.
No measurements were reported for this outcome.
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and measured in percentage.
| Percentage of total area of TM | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Change From Baseline in the Ratio of TMP Size Per Total Area of Tympanic Membrane at Week 12 for MAD | -0.2 ± 2.4 | 2.5 ± 2.3 | 0.3 ± 2.3 |
Ratio of TMP size per total area of tympanic membrane calculation was performed by central imaging vendor and measured in percentage.
No measurements were reported for this outcome.
TMP size calculation was be performed by central imaging vendor.
| mm^2 | MAD: 0.75 mcg | MAD: 2.25 mcg | MAD: Placebo |
|---|---|---|---|
| Change From Baseline in TMP Size at Week 12 for MAD | 1904.2 ± 18056.6 | 545.8 ± 9706.9 | -1237.3 ± 672.5 |
TMP size calculation was be performed by central imaging vendor.
No measurements were reported for this outcome.
Collected over SAD: From first dose up to day 57 MAD: From first dose up to day 85. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SAD: 0.03 mcg | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| SAD: ASP0598 0.15 mcg | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| SAD: ASP0598 0.75 mcg | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| SAD: ASP0598 2.25 mcg | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| SAD: Placebo | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| MAD: 0.75 mcg | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| MAD: ASP0598 2.25 mcg | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| MAD: Placebo | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Event | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo |
|---|---|---|---|---|---|---|---|---|
| Ear painEar and labyrinth disorders | 3/4 | 1/4 | 2/4 | 0/4 | 1/4 | 5/6 | 2/6 | 3/4 |
| Ear canal erythemaEar and labyrinth disorders | 1/4 | 0/4 | 0/4 | 0/4 | 0/4 | 2/6 | 1/6 | 2/4 |
| Ear discomfortEar and labyrinth disorders | 1/4 | 0/4 | 0/4 | 1/4 | 1/4 | 2/6 | 3/6 | 0/4 |
| Ear pruritusEar and labyrinth disorders | 2/4 | 0/4 | 1/4 | 1/4 | 0/4 | 0/6 | 1/6 | 0/4 |
| TinnitusEar and labyrinth disorders | 2/4 | 0/4 | 1/4 | 1/4 | 0/4 | 2/6 | 1/6 | 0/4 |
| HypoacusisEar and labyrinth disorders | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 2/6 | 0/6 | 0/4 |
| OtorrhoeaEar and labyrinth disorders | 1/4 | 0/4 | 0/4 | 1/4 | 0/4 | 2/6 | 0/6 | 0/4 |
| HeadacheNervous system disorders | 0/4 | 0/4 | 0/4 | 0/4 | 1/4 | 2/6 | 0/6 | 1/4 |
| Administration site painGeneral disorders | 0/4 | 0/4 | 0/4 | 1/4 | 0/4 | 0/6 | 0/6 | 0/4 |
| Application site pruritusGeneral disorders | 0/4 | 0/4 | 0/4 | 0/4 | 1/4 | 0/6 | 0/6 | 0/4 |
Safety Analysis Set (SAF) consisted of all randomized participants who received a dose of study drug.
| Age, Continuous(Years) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 32.5 ± 7.0 | 48.3 ± 20.4 | 50.8 ± 7.1 | 49.5 ± 16.0 | 51.5 ± 8.1 | 36.5 ± 18.6 | 44.3 ± 20.1 | 47.5 ± 14.0 | 45.11 ± 13.9 |
| Sex: Female, Male(Participants) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 3 | 4 | 2 | 2 | 2 | 2 | 1 | 18 |
| Male | 2 | 1 | 0 | 2 | 2 | 4 | 4 | 3 | 18 |
| Ethnicity (NIH/OMB)(Participants) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 |
| Not Hispanic or Latino | 4 | 4 | 3 | 4 | 3 | 6 | 6 | 4 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 4 |
| White | 4 | 3 | 3 | 3 | 3 | 5 | 5 | 3 | 29 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Bone Conduction Hearing at 1, 2,4 kilohertz (kHz) by Pure Tone Audiometry (PTA)(decibles) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| 1 kHz | 6.3 ± 7.5 | 6.3 ± 6.3 | 22.5 ± 20.2 | 11.3 ± 11.1 | 12.5 ± 9.6 | 1.7 ± 4.1 | 14.2 ± 15.3 | 3.8 ± 4.8 | 9.8 ± 9.9 |
| 2 kHz | 11.3 ± 10.3 | 11.3 ± 7.5 | 25.0 ± 14.7 | 22.5 ± 13.2 | 30.0 ± 21.2 | 10.0 ± 13.4 | 20.8 ± 14.6 | 10.0 ± 5.8 | 17.6 ± 12.5 |
| 4 kHz | 6.3 ± 6.3 | 15.0 ± 4.1 | 30.0 ± 24.2 | 28.8 ± 11.1 | 27.5 ± 25.3 | 9.2 ± 17.7 | 21.7 ± 15.4 | 17.5 ± 9.6 | 19.5 ± 14.2 |
| Tinnitus Visual Analog Scale (TVAS)(Score on a scale) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 1.0 ± 2.0 | 1.5 ± 3.0 | 3.0 ± 3.6 | 3.0 ± 3.8 | 2.5 ± 2.9 | 0.7 ± 1.6 | 3.3 ± 2.1 | 2.5 ± 2.1 | 2.2 ± 2.6 |
| Ratio of TMP size per total area of tympanic membrane(Percentage of total area of TM) | SAD: 0.03 mcg | SAD: ASP0598 0.15 mcg | SAD: ASP0598 0.75 mcg | SAD: ASP0598 2.25 mcg | SAD: Placebo | MAD: 0.75 mcg | MAD: ASP0598 2.25 mcg | MAD: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 10.3 ± 5.1 | 11.6 ± 8.1 | 4.7 ± 3.8 | 15.8 ± 11.7 | 7.3 ± 3.8 | 18.8 ± 13.4 | 17.1 ± 9.6 | 8.7 ± 6.7 | 11.8 ± 7.8 |
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Tympanic Membrane Perforation→
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