Table 1 Demographic and clinical characteristics at baseline (ITT population)
Placebo | 25 mg/d Neramexane | 50 mg/d Neramexane | 75 mg/d Neramexane | |||||
|---|---|---|---|---|---|---|---|---|
N = 111 | N = 106 | N = 106 | N = 99 | |||||
Mean ± SD | Mean ± SD | Mean ± SD | Mean ± SD | |||||
Age (years) | 45.7 ± 12.2 | 45.7 ± 11.8 | 44.9 ± 12.1 | 46.2 ± 11.8 | ||||
Height (m) | 1.75 ± 0.10 | 1.77 ± 0.10 | 1.75 ± 0.10 | 1.76 ± 0.09 | ||||
Weight (kg) | 78.81 ± 13.64 | 80.14 ± 14.16 | 77.23 ± 13.55 | 78.45 ± 12.73 | ||||
BMI (kg/m2) | 25.75 ± 3.33 | 25.48 ± 3.06 | 25.16 ± 3.21 | 25.29 ± 3.04 | ||||
Mean tinnitus duration (months) | 9.4 ± 4.64 | 9.5 ± 4.65 | 9.1 ± 4.17 | 8.8 ± 4.08 | ||||
THI-12 at baseline | 14.4 ± 3.7 | 14.4 ± 3.9 | 14.5 ± 3.3 | 13.9 ± 3.7 | ||||
n | % | n | % | n | % | n | % | |
Sex | ||||||||
Male | 76 | 68.5 | 75 | 70.8 | 72 | 67.9 | 68 | 68.7 |
Female | 35 | 31.5 | 31 | 29.2 | 34 | 32.1 | 31 | 31.3 |
Ethnic origin | ||||||||
Caucasian | 109 | 98.2 | 105 | 99.1 | 105 | 99.1 | 98 | 99.0 |
Asian | 0 | 0.0 | 0 | 0.0 | 1 | 0.9 | 1 | 1.0 |
Oriental | 1 | 0.9 | 1 | 0.9 | 0 | 0.0 | 0 | 0.0 |
Other | 1 | 0.9 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
Smoking habit | ||||||||
Non-smoker | 66 | 59.5 | 61 | 57.5 | 67 | 63.2 | 68 | 68.7 |
Smoker | 27 | 24.3 | 22 | 20.8 | 19 | 17.9 | 17 | 17.2 |
Ex-smoker | 18 | 16.2 | 23 | 21.7 | 20 | 18.9 | 14 | 14.1 |
Hearing loss (hearing threshold level) | ||||||||
None (<20 dB) | 64 | 57.7 | 65 | 61.3 | 61 | 57.5 | 61 | 61.6 |
Mild (20-40 dB) | 42 | 37.8 | 33 | 31,1 | 43 | 40.6 | 30 | 30.3 |
Moderate (>40-70 dB) | 5 | 4.5 | 8 | 7.5 | 1 | 0.9 | 5 | 5.1 |
Severe (>70-95 dB) | 0 | 0.0 | 0 | 0.0 | 1 | 0.9 | 3 | 3.0 |