Clinical Trial Results:
A 6-MONTH, MULTICENTER, PHASE 3, OPEN-LABEL EXTENSION SAFETY STUDY OF OTO-104 GIVEN AT 3-MONTH INTERVALS BY INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE’S DISEASE
Summary
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EudraCT number |
2016-000766-29 |
Trial protocol |
GB BE DE IT |
Global end of trial date |
05 Sep 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Dec 2021
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First version publication date |
13 Dec 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
104-201610
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02768662 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Otonomy, Inc.
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Sponsor organisation address |
4796 Executive Drive, San Diego, United States, 92121
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Public contact |
Medical Information, Otonomy Inc., medinfo@otonomy.com
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Scientific contact |
Medical Information, Otonomy Inc., medinfo@otonomy.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Sep 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Sep 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The objective is to assess the safety of repeat intratympanic injections of 12 mg OTO-104 at 3-month intervals in an open-label study in subjects with unilateral Meniere’s disease.
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Protection of trial subjects |
Not Applicable
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Background therapy |
Subjects were permitted to continue medications for relief of symptoms related to Meniere’s disease during the course of the study. Intermittent use of vestibular suppressants and anti-emetics was allowed as symptomatic relief medications. Subjects were allowed to take betahistine as well. | ||
Evidence for comparator |
Not Applicable - no comparator | ||
Actual start date of recruitment |
20 Jul 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 83
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Country: Number of subjects enrolled |
Poland: 23
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Country: Number of subjects enrolled |
Belgium: 6
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Country: Number of subjects enrolled |
France: 4
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Country: Number of subjects enrolled |
Germany: 17
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Country: Number of subjects enrolled |
Italy: 9
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Worldwide total number of subjects |
142
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EEA total number of subjects |
59
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
123
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From 65 to 84 years |
19
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85 years and over |
0
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Recruitment
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Recruitment details |
This was a 6-month, multicenter, Phase 3, open-label extension safety study in subjects with unilateral Meniere’s disease that had previously completed the Phase 2 (104-201403) or Phase 3 (104-201508) studies. | ||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects that completed one of the prior studies were asked if they wanted to participate in this study and if so, they signed an informed consent. | ||||||||||||||||||||
Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
Blinding implementation details |
This was an open-label study and therefore, no blinding was required.
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Arms
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Arm title
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OTO-104 | ||||||||||||||||||||
Arm description |
dexamethasone suspension in a solution of poloxamer 407 | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
OTO-104
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intratympanic use
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Dosage and administration details |
The tympanic membrane was anesthetized by covering the external surface of the inferior-posterior quadrant with topical lidocaine or lidocaine/prilocaine cream. 200 microliters of a 6% w/v suspension of dexamethasone (12 mg) was administered via intratympanic injection by inserting the needle into the inferior-posterior quadrant of the tympanic membrane at the level of the round window.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
All subjects that received at least one intratympanic injection of OTO-104. | ||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||
Subject analysis set description |
The safety analysis set included all subjects who received at least one dose of study drug.
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End points reporting groups
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Reporting group title |
OTO-104
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Reporting group description |
dexamethasone suspension in a solution of poloxamer 407 | ||
Subject analysis set title |
Safety
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety analysis set included all subjects who received at least one dose of study drug.
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End point title |
Tympanic Membrane Perforation [1] | ||||||||||||
End point description |
Perforations were rated as "Present" or "Not Present"; if a subject did not receive an otoscopy, then the perforation is listed as "Missing".
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End point type |
Primary
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End point timeframe |
Up to 6 months; otoscopy examinations were performed at 3 and 6 months in the ear that received the injection(s).
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint for this study was safety in nature and as such, no additional statistics were performed other than summary statistics. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From Day 1 to end of study, which could have been up to Month 6.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
OTO-104
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Reporting group description |
dexamethasone suspension in a solution of poloxamer 407 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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26 Apr 2016 |
- Added EudraCT number to title page
- Removed telephone as a method to report SAEs.
- Added safety fax number as a back-up contact method for reporting SAEs.
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |