Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (TACTT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01270282
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

Tracking Information
First Submitted Date  ICMJE December 30, 2010
First Posted Date  ICMJE January 5, 2011
Last Update Posted Date January 26, 2015
Study Start Date  ICMJE February 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection [ Time Frame: 90 or 104 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
Change in the minimum masking level in dB from Baseline to Day 90 [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
  • Standard audiological evaluations [ Time Frame: 90 or 104 days ]
    Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
  • Questionnaires evaluating the impact of tinnitus [ Time Frame: 90 or 104 days ]
    Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
  • Pharmacokinetic measures [ Time Frame: 3 or 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
  • Standard audiological evaluations [ Time Frame: 90 days ]
    Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
  • Questionnaires evaluating the impact of tinnitus [ Time Frame: 90 days ]
    Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
  • Pharmacokinetic measures [ Time Frame: 3 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Official Title  ICMJE Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Brief Summary The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Drug: AM-101 0.81 mg/mL
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: AM-101 0.81 mg/mL
    Gel for injection; single or triple injection
    Intervention: Drug: AM-101 0.81 mg/mL
  • Placebo Comparator: Placebo
    Gel for injection; single or triple injection
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2013)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2011)
24
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.

Exclusion Criteria:

  • Tinnitus that is not completely maskable
  • Fluctuating tinnitus
  • Intermittent tinnitus
  • Meniere's Disease
  • Ongoing acute or chronic otitis media or otitis externa.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01270282
Other Study ID Numbers  ICMJE AM-101-CL-10-02
AM-101-CL-10-02 ( Other Identifier: Auris Medical )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Auris Medical, Inc.
Study Sponsor  ICMJE Auris Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Auris Medical, Inc.
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP