Table 1.
Study disposition and demographics
| Parameter | Placebo (n = 76) | Doxepin 3 mg (n = 77) | Doxepin 6 mg (n = 76) | Total (n = 229) |
|---|---|---|---|---|
| Completed study | 88% | 88% | 89% | 89% |
| Discontinued from study | 12% | 12% | 11% | 11% |
| Reason: Adverse Event | 1% | 3% | 4% | 3% |
| Reason: Consent Withdrawn | 4% | 3% | 0% | 2% |
| Reason: Protocol Violation | 0% | 1% | 0% | < 1% |
| Reason: Noncompliance | 3% | 3% | 3% | 3% |
| Reason: Other | 4% | 3% | 4% | 4% |
| Age (years) | (n = 73) | (n = 75) | (n = 73) | (n = 221)1 |
| Mean (SD) | 43.6 (12.3) | 45.5 (10.6) | 44.2 (11.1) | 44.5 (11.3) |
| Range | 18–64 | 20–64 | 19–63 | 18–64 |
| BMI (kg/m2) | (n = 73) | (n = 75) | (n = 73) | (n = 221)1 |
| Mean (SD) | 26.4 (4.5) | 27.8 (4.9) | 27.4 (4.1) | 27.2 (4.6) |
| Range | 18.2–40.6 | 19.1–41.5 | 19.2–38.0 | 18.2–41.5 |
| Gender | (n = 73) | (n = 75) | (n = 73) | (n = 221)1 |
| Female | 70% | 77% | 71% | 73% |
| Male | 30% | 23% | 29% | 27% |
| Race/Ethnicity | (n = 73) | (n = 75) | (n = 73) | (n = 221)1 |
| Caucasian | 48% | 44% | 53% | 48% |
| African American | 34% | 35% | 29% | 33% |
| Hispanic | 15% | 20% | 14% | 16% |
| Other | 2% | 1% | 4% | 3% |
1
Eight patients who did not receive study drug are not included in these data sets (N = 221).