Phase 3 study of OTO-104 intratympanic injections in subjects with Meniere's disease.

Phase 1

• Conditions: MedDRA version: 19.0 Level: PT Classification code 10027183 Term: Meniere's disease System Organ Class: 10013993 - Ear and labyrinth disorders; Meniere's disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000766-29-GB
• Lead Sponsor: Otonomy Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Subject is a male or female aged 18 years or older.
2. Subject has completed the Phase 2 (104-201403) or Phase 3 (104-201508) clinical study.
3. Female subjects of childbearing potential [i.e., not surgically sterile and/or not post-menopausal (12 months since last menstrual period and 45 years of age or older)] must have a negative urine pregnancy test before enrollment. Women of childbearing potential who are not abstinent from sex with male partners may be entered into the study if they are using and willing to continue to use highly effective or double barrier contraceptive precautions for the duration of the study (e.g., oral contraceptives, contraceptive implant or injection, intrauterine device, or double barrier methods including condom with diaphragm, male condom with cervical cap, male condom with spermicide, or diaphragm and spermicide).
4. Subject is willing to comply with the protocol and attend all study visits.
5. Subject is able to provide written informed consent, including agreement to local privacy language requirements either within the informed consent or in ancillary documents compliant with local privacy laws before the initiation of any study-related procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

1. Subject has an infection in the ear, sinuses, or upper respiratory system.
2. Subject is pregnant or lactating.
3. Subject has a history of immunodeficiency disease.
4. Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
5. Subject has an abnormality of the tympanic membrane in the affected ear that would increase the risk associated with intratympanic injection including but not limited to a monomeric, atelectatic or atrophic tympanic membrane.
6. Subject has a history of tympanostomy tubes that includes evidence of perforation or lack of closure.
7. Subject has a history of previous endolymphatic sac surgery.
8. Subject has a history of previous use of intratympanic gentamicin in the affected ear.
9. Subject has history of drop attacks.
10. Subject has used systemic steroids within 1 month prior to Visit 1.
11. Subject has had intratympanic steroids within 1 month prior to Visit 1.
12. Subject has experienced an adverse reaction to intratympanic injection of steroids.
13. Subject has a hypersensitivity to dexamethasone or any of the excipients in OTO-104.
14. Subject has any other clinically significant illness or medical condition that, in the investigator's and the medical monitor's opinion, would prohibit the subject from participating in the study.
15. Subject has participated in a clinical trial within 30 days of Visit 1, not including the OTO-104 Phase 3 study (104-201508).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified