Trial · NCT02600559

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

NCT02600559, Phase 3, Completed, Otonomy, Inc.; results first posted 2020-09-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes. Trials, record NCT02600559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02600559

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
NCT number: NCT02600559
Status: Completed
Phases: Phase 3
Enrollment: 501 participants, actual
Lead sponsor: Otonomy, Inc.
Conditions: Otitis Media
Interventions: OTO-201 (ciprofloxacin)
First posted: 2015-11-09
Last updated: 2020-10-19
Results first posted: 2020-09-22

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With Post-surgical Otorrhea	Week 4	Absence or presence of otorrhea (drainage from the middle ear)
Primary	Number of Subjects With Post-surgical Otorrhea	8 weeks	Absence or presence of otorrhea (drainage from the middle ear)
Secondary	Adverse Events	Up to Eight Weeks	Evaluation of adverse events
Secondary	Caregiver Burden - Ear Discharge Control	Week 4	Ear Drop Caregiver Burden Questionnaire at Week 4
Secondary	Caregiver Burden - Ear Discharge Control	Week 8	Ear Drop Caregiver Burden Questionnaire at Week 8
Secondary	Caregiver Burden - Ear Drops Administration	Week 8	Ear Drop Caregiver Burden Questionnaire at Week 8

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Post-surgical Otorrhea	Week 4	Safety analysis set: All subjects who received study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Post-surgical Otorrhea	8 weeks	Safety analysis set: All subjects who received study drug	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events	Up to Eight Weeks	Safety analysis set: All subjects who received study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Caregiver Burden - Ear Discharge Control	Week 4	Safety analysis set: All subjects who received study drug and whose caregiver completed the questionnaire at Week 4	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Caregiver Burden - Ear Discharge Control	Week 8	Safety analysis set: All subjects who received study drug, and had a completed questionnaire at Week 8	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Caregiver Burden - Ear Drops Administration	Week 8	Safety analysis set: All subject who received study drug, and who had to be treated with ear drops after tube placement surgery.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Subjects With Post-surgical Otorrhea	6 mg OTO-201	Absence of Otorrhea	383	Participants
Number of Subjects With Post-surgical Otorrhea	6 mg OTO-201	Presence of Otorrhea	118	Participants
Number of Subjects With Post-surgical Otorrhea	6 mg OTO-201	Absence of Otorrhea	334	Participants
Number of Subjects With Post-surgical Otorrhea	6 mg OTO-201	Presence of Otorrhea	167	Participants
Adverse Events	6 mg OTO-201	Subjects with AEs	250	Participants
Adverse Events	6 mg OTO-201	Subjects without AEs	251	Participants
Caregiver Burden - Ear Discharge Control	6 mg OTO-201	Satisfied with control of ear discharge	481	Participants
Caregiver Burden - Ear Discharge Control	6 mg OTO-201	Not satisfied with control of ear discharge	4	Participants
Caregiver Burden - Ear Discharge Control	6 mg OTO-201	Satisfied with control of ear discharge	470	Participants
Caregiver Burden - Ear Discharge Control	6 mg OTO-201	Not satisfied with control of ear discharge	5	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	6 mg OTO-201	501
Overall Study	COMPLETED	6 mg OTO-201	478
Overall Study	NOT COMPLETED	6 mg OTO-201	23

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Upper Respiratory Infection	Infections and infestations	6 mg OTO-201	35	501
other	Nasopharyngitis	Infections and infestations	6 mg OTO-201	13	501
other	Sinusitis	Infections and infestations	6 mg OTO-201	12	501
other	Otitis Media	Infections and infestations	6 mg OTO-201	11	501
other	Pharyngitis streptococcal	Infections and infestations	6 mg OTO-201	8	501
other	Device occlusion	General disorders	6 mg OTO-201	67	501
other	Pyrexia	General disorders	6 mg OTO-201	41	501
other	Device extrusion	General disorders	6 mg OTO-201	9	501
other	Rhinorrhea	Respiratory, thoracic and mediastinal disorders	6 mg OTO-201	19	501
other	Nasal Congestion	Respiratory, thoracic and mediastinal disorders	6 mg OTO-201	12	501

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	6 mg OTO-201	0	501
Total, other adverse events	6 mg OTO-201	200	501
Total, serious adverse events	6 mg OTO-201	1	501

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02600559

GET https://conductscience.org/api/trials/v1/NCT02600559/registered

API reference For AI assistants