Table 1 Patient demographics and baseline characteristics in intent-to-treat population
Characteristic | NTG 0.4% | Placebo | Pvalue (2-sided)* |
|---|---|---|---|
(n = 123) | (n = 124) | ||
Mean age, y (SD) | 46.5 (12.6) | 43.4 (13.2) | .057 |
Male, n (%) | 65 (52.8) | 66 (53.2) | 1 |
Race, n (%) | .640 | ||
White | 99 (80.5) | 96 (77.4) | |
Black | 21 (17.1) | 16 (12.9) | |
Baseline VAS, n (%) | .899 | ||
Moderate 50–69 mm | 57 (46.3) | 59 (47.2) | |
Severe ≥70 mm | 66 (53.7) | 65 (52.0) | |
Most common medical conditions, n (%) (≥20 patients in either treatment group) | |||
Gastrointestinal disorders | |||
Constipation | 29 (23.6) | 28 (22.6) | .881 |
Hemorrhoids | 27 (22.0) | 23 (18.5) | .530 |
Gastroesophageal reflux disease | 20 (16.3) | 17 (13.7) | .597 |
Other disorders | |||
Drug hypersensitivity | 26 (21.1) | 18 (14.5) | .187 |
Hypertension | 38 (30.9) | 29 (23.4) | .200 |
Hypercholesterolemia | 23 (18.7) | 15 (12.1) | .162 |