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Management decision
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The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-60371/AL-817 | Experimental | AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) |
|
| CIPRODEX | Active Comparator | Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-60371/AL-817 otic suspension | Drug |
| ||
| Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit | A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage. | Day 3 post-treatment up to Day 8 or Early Exit |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Microbiological Success at the Day 8 Visit | Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success. | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, GCRA, Pharma | Alcon Research | Study Director |
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Of the 84 enrolled, 14 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (70).
Subjects were recruited from 12 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AL-60371/AL-817 | 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) |
| FG001 | CIPRODEX | Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
CIPRODEX® |
|
| Median Time (in Days) to Cessation of Otorrhea |
Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries. |
| Time to event, up to Day 8 |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
This analysis population includes all randomized and treated subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | AL-60371/AL-817 | 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) |
| BG001 | CIPRODEX | Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit | A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage. | This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear. | Posted | Number | percentage of subjects | Day 3 post-treatment up to Day 8 or Early Exit |
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| |||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Microbiological Success at the Day 8 Visit | Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success. | This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear. | Posted | Mean | Standard Deviation | percentage of subjects | Day 8 |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Time (in Days) to Cessation of Otorrhea | Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries. | This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear. | Posted | Median | Standard Error | days | Time to event, up to Day 8 |
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Adverse events (AEs) were collected for the duration of subject participation in the study (8-10 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-treatment | Includes all subjects prior to administration of study medication | 0 | 84 | 0 | 84 | ||
| EG001 | AL-60371/AL-817 | Includes all subjects administered a dose of AL-60371/AL-817 | 0 | 44 | 3 | 44 | ||
| EG002 | CIPRODEX | Includes all subjects administered a dose of CIPRODEX® | 0 | 24 | 1 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media acute | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Clinical Project Lead, GCRA, Pharma | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Male |
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