Trial record 4 of 7 for:
am101
AM-101 in the Treatment of Acute Tinnitus 2 (TACTT2)
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| ClinicalTrials.gov Identifier: NCT01803646 |
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Recruitment Status :
Completed
First Posted : March 4, 2013
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
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Sponsor:
Auris Medical, Inc.
Information provided by (Responsible Party):
Auris Medical, Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Tinnitus |
| Interventions |
Drug: AM-101 Drug: Placebo |
| Enrollment | 343 |
Participant Flow
| Recruitment Details | A total of 86 sites were initiated in Canada, the United States, the Czech Republic, Israel, Turkey and Republic of South Korea. In total, 69 sites screened each at least 1 subject and 64 sites randomized subjects for treatment. |
| Pre-assignment Details |
A total of 478 subjects were screened, 343 subjects were randomized, and 336 subjects were treated. 7 subjects were randomized (3 to AM-101 and 4 to placebo) but not treated; these subjects were excluded from the analysis sets. The majority (92%) of subjects completed the study. |
| Arm/Group Title | AM-101 0.87 mg/mL Gel | Placebo Gel |
|---|---|---|
 Arm/Group Description |
Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4) | Three intratympanic administration of placebo gel within 5 days (D0-D4). |
| Period Title: Overall Study | ||
| Started | 204 | 139 |
| Completed | 187 | 129 |
| Not Completed | 17 | 10 |
| Reason Not Completed | ||
| Protocol Violation | 1 | 0 |
| Adverse Event | 1 | 1 |
| Withdrawal by Subject | 9 | 6 |
| Randomization error | 1 | 2 |
| Lost to Follow-up | 5 | 1 |
Baseline Characteristics
| Arm/Group Title | AM-101 0.87 mg/mL Gel | Placebo Gel | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4) | Three intratympanic administration of placebo gel within 5 days (D0-D4). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 204 | 139 | 343 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 204 participants | 139 participants | 343 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
188 92.2%
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125 89.9%
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313 91.3%
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| >=65 years |
16 7.8%
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14 10.1%
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30 8.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 204 participants | 139 participants | 343 participants | |
| 43.4 (14.6) | 44.2 (15.2) | 43.7 (14.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 204 participants | 139 participants | 343 participants | |
| Female |
43 21.1%
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37 26.6%
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80 23.3%
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| Male |
161 78.9%
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102 73.4%
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263 76.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 204 participants | 139 participants | 343 participants |
| United States | 122 | 82 | 204 | |
| Czechia | 38 | 26 | 64 | |
| Canada | 20 | 14 | 34 | |
| Israel | 2 | 1 | 3 | |
| South Korea | 15 | 12 | 27 | |
| Turkey | 7 | 4 | 11 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator agrees to submit a copy of any intended communication, presentation or publication (abstract, poster, article, etc.) (all together "Communication") at least 2 month in advance of the submission of proposed Communication. The Sponsor shall have 60 days, after receipt of said copies, to object to such proposed Communication. In case of such objection, the Investigator shall refrain from making such Communication for 6 months from date of receipt of such objection.
Results Point of Contact
| Name/Title: | Thomas Meyer, CEO |
| Organization: | Auris Medical Inc. |
| Phone: | +1 312 396 4150 |
| EMail: | hear@aurismedical.com |
| Responsible Party: | Auris Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01803646 |
| Other Study ID Numbers: |
AM-101-CL-12-01 |
| First Submitted: | March 1, 2013 |
| First Posted: | March 4, 2013 |
| Results First Submitted: | January 18, 2018 |
| Results First Posted: | May 29, 2018 |
| Last Update Posted: | May 29, 2018 |