Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study

Table 3 Complete resolution rate of symptoms after treatment (per protocol set)

	HIP1601 (n = 93)			HGP1705 (n = 94)			P-value^†
	Baseline	Week 4	Week 8^*	Baseline	Week 4	Week 8^*
Overall symptoms	92	46 (49.5%)	48 (51.6%)	94	46 (48.9%)	47 (50.0%)	0.941^***
Overall symptoms	92	46 (49.5%)	48 (51.6%)	94	46 (48.9%)	47 (50.0%)	0.943^****
P-value^**		< 0.001	< 0.001		< 0.001	< 0.001
Heartburn and acid regurgitation	60	28 (46.7%)	30 (50.0%)	64	37 (57.8%)	37 (57.8%)	0.214^***
Heartburn and acid regurgitation	60	28 (46.7%)	30 (50.0%)	64	37 (57.8%)	37 (57.8%)	0.383^****
P-value^**		0.004	0.002		< 0.001	< 0.001
Heartburn	77	49 (63.6%)	50 (64.9%)	76	55 (72.4%)	55 (72.4%)	0.247^***
Heartburn	77	49 (63.6%)	50 (64.9%)	76	55 (72.4%)	55 (72.4%)	0.322^****
P-value^**		< 0.001	< 0.001		< 0.001	< 0.001
Acid regurgitation	75	51 (68.0%)	52 (69.3%)	77	51 (66.2%)	52 (67.5%)	0.817^***
Acid regurgitation	75	51 (68.0%)	52 (69.3%)	77	51 (66.2%)	52 (67.5%)	0.811^****
P-value^**		< 0.001	< 0.001		< 0.001	< 0.001
Dysphagia	11	4 (36.4%)	4 (36.4%)	18	10 (55.6%)	10 (55.6%)	0.316^***
Dysphagia	11	4 (36.4%)	4 (36.4%)	18	10 (55.6%)	10 (55.6%)	0.316^****
P-value^**		0.705	0.705		0.467	0.317
Epigastric pain	36	25 (69.4%)	26 (72.2%)	42	29 (69.0%)	30 (71.4%)	0.970^***
Epigastric pain	36	25 (69.4%)	26 (72.2%)	42	29 (69.0%)	30 (71.4%)	0.938^****
P-value^**		0.011	0.004		0.004	0.002

The complete resolution rate was defined proportion of patients with ‘score 0’ of severity during the last 7 days prior to the visit
*Cumulative complete resolution rate of symptoms by week 8
**P-value for comparison of before/after administration using McNemar’s test
*** P-value for week 4 Using Chi-squre test or Fisher’s exact test
**** P-value for week 8 Using Chi-squre test or Fisher’s exact test

ISSN: 1471-230X