Trial Outcomes & Findings for Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes (NCT NCT02600559)

NCT ID: NCT02600559

Last Updated: 2020-10-19

Results Overview

Absence or presence of otorrhea (drainage from the middle ear)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 501 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2020-10-19

Participant Flow

There were a total of 518 subjects screened for this study. There were 17 subjects considered screen failures, with the majority (11) failing to meet inclusion/exclusion criteria. Therefore, 501 subjects were assigned for treatment in this study and are designated as "enrolled".

Participant milestones

Measure	6 mg OTO-201 6 mg ciprofloxacin: single administration
Overall Study STARTED	501
Overall Study COMPLETED	478
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	6 mg OTO-201 6 mg ciprofloxacin: single administration
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	20

Baseline Characteristics

Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Baseline characteristics by cohort

Measure	6 mg OTO-201 n=501 Participants 6 mg ciprofloxacin: single administration
Age, Categorical <=18 years	501 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	2.9 years STANDARD_DEVIATION 2.54 • n=5 Participants
Sex: Female, Male Female	216 Participants n=5 Participants
Sex: Female, Male Male	285 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	403 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants
Race (NIH/OMB) White	415 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	36 Participants n=5 Participants
Region of Enrollment United States	501 participants n=5 Participants
Medicaid (Yes/No) Medicaid - Yes	165 Participants n=5 Participants
Medicaid (Yes/No) Medicaid - No	336 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Safety analysis set: All subjects who received study drug.

Absence or presence of otorrhea (drainage from the middle ear)

Outcome measures

Measure	6 mg OTO-201 n=501 Participants 6 mg ciprofloxacin: single administration
Number of Subjects With Post-surgical Otorrhea Absence of Otorrhea	383 Participants
Number of Subjects With Post-surgical Otorrhea Presence of Otorrhea	118 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis set: All subjects who received study drug

Absence or presence of otorrhea (drainage from the middle ear)

Outcome measures

Measure	6 mg OTO-201 n=501 Participants 6 mg ciprofloxacin: single administration
Number of Subjects With Post-surgical Otorrhea Absence of Otorrhea	334 Participants
Number of Subjects With Post-surgical Otorrhea Presence of Otorrhea	167 Participants

SECONDARY outcome

Timeframe: Up to Eight Weeks

Population: Safety analysis set: All subjects who received study drug.

Evaluation of adverse events

Outcome measures

Measure	6 mg OTO-201 n=501 Participants 6 mg ciprofloxacin: single administration
Adverse Events Subjects with AEs	250 Participants
Adverse Events Subjects without AEs	251 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Safety analysis set: All subjects who received study drug and whose caregiver completed the questionnaire at Week 4

Ear Drop Caregiver Burden Questionnaire at Week 4

Outcome measures

Measure	6 mg OTO-201 n=485 Participants 6 mg ciprofloxacin: single administration
Caregiver Burden - Ear Discharge Control Satisfied with control of ear discharge	481 Participants
Caregiver Burden - Ear Discharge Control Not satisfied with control of ear discharge	4 Participants

SECONDARY outcome

Timeframe: Week 8

Population: Safety analysis set: All subjects who received study drug, and had a completed questionnaire at Week 8

Ear Drop Caregiver Burden Questionnaire at Week 8

Outcome measures

Measure	6 mg OTO-201 n=475 Participants 6 mg ciprofloxacin: single administration
Caregiver Burden - Ear Discharge Control Not satisfied with control of ear discharge	5 Participants
Caregiver Burden - Ear Discharge Control Satisfied with control of ear discharge	470 Participants

SECONDARY outcome

Timeframe: Week 8

Population: Safety analysis set: All subject who received study drug, and who had to be treated with ear drops after tube placement surgery.

Ear Drop Caregiver Burden Questionnaire at Week 8

Outcome measures

Measure	6 mg OTO-201 n=71 Participants 6 mg ciprofloxacin: single administration
Caregiver Burden - Ear Drops Administration Bothersome to administer ear drops	48 Participants
Caregiver Burden - Ear Drops Administration Not bothersome to administer ear drops	23 Participants

Adverse Events

6 mg OTO-201

Serious events: 1 serious events

Other events: 200 other events

Deaths: 0 deaths

Serious adverse events

Measure	6 mg OTO-201 n=501 participants at risk 6 mg ciprofloxacin: single administration
Infections and infestations Influenza	0.20% 1/501 • Number of events 501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.

Other adverse events

Measure	6 mg OTO-201 n=501 participants at risk 6 mg ciprofloxacin: single administration
Infections and infestations Upper Respiratory Infection	7.0% 35/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Infections and infestations Nasopharyngitis	2.6% 13/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Infections and infestations Sinusitis	2.4% 12/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Infections and infestations Otitis Media	2.2% 11/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Infections and infestations Pharyngitis streptococcal	1.6% 8/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
General disorders Device occlusion	13.4% 67/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
General disorders Pyrexia	8.2% 41/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
General disorders Device extrusion	1.8% 9/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.8% 19/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.4% 12/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Ear and labyrinth disorders Ear Pain	5.2% 26/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Gastrointestinal disorders Vomiting	2.4% 12/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
Injury, poisoning and procedural complications Procedural pain	2.4% 12/501 • Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.

Additional Information

Medical Information Call Center

Otonomy, Inc.

Phone: 1-800-826-6411

Email: medinfo@otonomy.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication subject to Sponsor consent.
• Publication restrictions are in place

Restriction type: OTHER