Table 3.

Changes in efficacy variables from baseline to week 12

	KRP‐116D	Placebo
	(n = 49)	(n = 47)
ICPI
No. of subjects at week 12	48	45
LS mean change at week 12 from baseline	−4.9	−2.4
95% CI	(−5.9, −3.8)	(−3.5, −1.3)
Estimated difference	−2.5	–
95% CI for estimated difference	(−4.0, −1.0)	–
P‐value	0.0014	–
Number of micturitions per 24 h
No. of subjects at week 12	48	45
LS mean change at week 12 from baseline	−3.86	−1.75
95% CI	(−4.91, −2.80)	(−2.83, −0.67)
Estimated difference	−2.11	–
95% CI for estimated difference	(−3.62, −0.60)	–
P‐value	0.0068	–
Voided volume per micturition
No. of subjects at week 12	48	45
LS mean change at week 12 from baseline, mL	38.8	14.0
95% CI	(27.1, 50.6)	(2.0, 26.0)
Estimated difference	24.8	–
95% CI for estimated difference	(8.0, 41.6)	–
P‐value	0.0042	–
Maximum voided volume per micturition
No. of subjects at week 12	48	45
LS mean change at week 12 from baseline, mL	43.8	9.0
95% CI	(28.4, 59.2)	(−6.8, 24.7)
Estimated difference	34.8	–
95% CI for estimated difference	(12.8, 56.8)	–
P‐value	0.0023	–
Change of maximum voided volume per micturition
No. of subjects at week 12	48	45
LS mean change at week 12 from baseline, %	29.89	11.54
95% CI	(20.09, 39.70)	(1.55, 21.54)
Estimated difference	18.35	–
95% CI for estimated difference	(4.34, 32.35)	–
P‐value	0.0108	–
NRS score for bladder pain
No. of subjects at week 12	48	45
LS mean change at week 12 from baseline	−2.87	−2.09
95% CI	(−3.52, −2.22)	(−2.75, −1.42)
Estimated difference	−0.78	–
95% CI of estimated difference	(−1.71, 0.15)	–
P‐value	0.0973	–

Analysis set: full analysis set.