Table 1.
Summary of demographic and other baseline characteristics
| KRP‐116D (n = 49) | Placebo (n = 47) | |
|---|---|---|
| Sex, n (%) | ||
| Male | 6 (12.2) | 3 (6.4) |
| Female | 43 (87.8) | 44 (93.6) |
| Age | ||
| <65 years, n (%) | 21 (42.9) | 19 (40.4) |
| ≥65 years, n (%) | 28 (57.1) | 28 (59.6) |
| Mean ± SD | 63.6 ± 14.2 | 64.5 ± 13.5 |
| (Minimum, median, maximum) | (30, 66.0, 87) | (36, 67.0, 87) |
| Height, cm | ||
| Mean ± SD | 155.14 ± 8.58 | 154.28 ± 7.50 |
| (Minimum, median, maximum) | (139.0, 152.90, 179.7) | (135.4, 154.10, 171.1) |
| Weight | ||
| <50 kg, n (%) | 20 (40.8) | 19 (40.4) |
| ≥50 kg, n (%) | 29 (59.2) | 28 (59.6) |
| Mean ± SD | 55.80 ± 11.79 | 52.88 ± 11.52 |
| (Minimum, median, maximum) | (38.6, 53.60, 90.0) | (29.6, 52.80, 86.8) |
| Body mass index | ||
| <25.0 kg/m2, n (%) | 37 (75.5) | 39 (83.0) |
| ≥25.0 kg/m2, n (%) | 12 (24.5) | 8 (17.0) |
| Mean ± SD | 23.08 ± 3.87 | 22.12 ± 4.18 |
| (Minimum, median, maximum) | (17.6, 22.83, 34.9) | (14.5, 21.39, 36.0) |
| Type of IC, n (%) | ||
| Hunner type | 42 (85.7) | 41 (87.2) |
| Non‐Hunner type | 7 (14.3) | 6 (12.8) |
| ICSI | ||
| Mean ± SD | 13.9 ± 3.1 | 13.7 ± 3.1 |
| (Minimum, median, maximum) | (9, 14.0, 20) | (9, 13.0, 20) |
| ICPI | ||
| Mean ± SD | 12.0 ± 3.2 | 11.8 ± 3.0 |
| (Minimum, median, maximum) | (4, 13.0, 16) | (6, 12.0, 16) |
| Mean number of micturitions per 24 h† | ||
| Mean ± SD | 16.41 ± 9.41 | 14.93 ± 5.72 |
| (Minimum, median, maximum) | (8.0, 15.00, 56.5) | (8.0, 13.50, 37.0) |
| Mean voided volume per micturition (mL)† | ||
| Mean ± SD | 109.4 ± 54.8 | 114.1 ± 58.5 |
| (Minimum, median, maximum) | (27, 105.8, 257) | (31, 104.4, 305) |
| Maximum voided volume per micturition (mL)† | ||
| Mean ± SD | 183.5 ± 104.2 | 184.4 ± 104.0 |
| (Minimum, median, maximum) | (50, 185.0, 600) | (45, 165.0, 500) |
| NRS for bladder pain ‡ | ||
| Mean ± SD | 6.50 ± 1.46 | 6.51 ± 1.50 |
| (Minimum, median, maximum) | (4.0, 6.33, 10.0) | (4.0, 6.33, 10.0) |
| History of hydrodistention, n (%) | ||
| No | 6 (12.2) | 9 (19.1) |
| Yes | 43 (87.8) | 38 (80.9) |
| <1 year | 18 (36.7) | 15 (31.9) |
| ≥1 year | 25 (51.0) | 23 (48.9) |
| History of DMSO intravesical instillation, n (%) | ||
| No | 43 (87.8) | 42 (89.4) |
| Yes | 6 (12.2) | 5 (10.6) |
| Use of drug for primary disease at screening, n (%) | ||
| No | 9 (18.4) | 16 (34.0) |
| Yes | 40 (81.6) | 31 (66.0) |
| Antihistamine | 4 (8.2) | 3 (6.4) |
| Antidepressants/antipsychotics | 8 (16.3) | 12 (25.5) |
| Suplatast tosylate | 14 (28.6) | 17 (36.2) |
| Systemic steroids | 2 (4.1) | 0 (0.0) |
| Acidic urine remedy | 3 (6.1) | 4 (8.5) |
| Drugs for overactive bladder/urination disorder | 9 (18.4) | 12 (25.5) |
| Analgesics | 23 (46.9) | 16 (34.0) |
| Others | 10 (20.4) | 10 (21.3) |
Analysis set: full analysis set.
†
Mean of the latest 2 days before week 0.
‡
Mean of the latest 3 days before week 0.