Treatment of Acute Peripheral Tinnitus Following Traumatic Cochlear Injury or Otitis Media (TACTT2)
This study is not yet open for participant recruitment.
Verified August 2013 by Auris Medical, Inc.
Information provided by (Responsible Party):
Auris Medical, Inc.
First received: March 1, 2013
Last updated: November 29, 2013
Last verified: August 2013
This phase III study is being conducted to confirm the efficacy and safety of AM-101 in the treatment of peripheral tinnitus in the acute stage (up to 3 months from onset).
Acute Peripheral Tinnitus
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Treatment of Acute Peripheral Tinnitus Following Traumatic Cochlear Injury or Otitis Media
Primary Outcome Measures:
- Tinnitus loudness [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Improvement in patient-reported tinnitus loudness (TLQ NRSLoudest) from baseline to Day 90.
- Deterioration in hearing threshold [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
Occurrence of deterioration in hearing threshold ≥ 15 decibel (dB) from baseline to Day 30 at the average of two contiguous test frequencies (air conduction) in the treated ear. It will be conducted with air and bone conduction hearing threshold values.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Active Comparator: AM-101 Injection
Gel for i.t. injection
Placebo Comparator: Placebo Injection
Placebo gel for i.t. injection
The present study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated i.t. AM 101 injections in the treatment of acute peripheral tinnitus.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months prior to randomization
- Age ≥ 18 years and ≤ 75 years;
- Negative pregnancy test;
- Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
- Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed;
Other protocol-defined inclusion criteria may apply.
- Fluctuating tinnitus;
- Intermittent tinnitus;
- Tinnitus resulting from traumatic head or neck injury;
- Presence of chronic tinnitus;
- Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
- History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
- Ongoing acute or chronic otitis media or otitis externa;
- Other treatment of tinnitus for the study duration;
- Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
- Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
- Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
- Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.
Other protocol-defined exclusion criteria may apply.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803646
Auris Medical, Inc.
No publications provided
||Auris Medical, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 1, 2013
||November 29, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Nervous System Diseases
Signs and Symptoms