Efficacy and safety of rebamipide/nizatidine in patients with erosive gastritis: A randomized, multicenter, phase 4 study

Table 3 Treatment outcomes, n (%)

	Rebamipide/nizatidine	Nizatidine	P value
FAS
Total number of patients	121	118
Primary outcome
Erosion improvement	75/121 (62.0)	58/118 (49.2)	0.046
Secondary outcome
Erosion cure	62/121 (51.2)	50/118 (42.4)	0.170
Bleeding improvement	26/35 (74.3)	30/40 (75.0)	0.943
Erythema improvement	38/86 (44.2)	43/86 (50.0)	0.445
Edema cure	22/35 (62.9)	19/27 (70.4)	0.535
Symptom improvement	74/121 (61.2)	67/118 (56.8)	0.492
Erosion improvement in symptomatic subjects1	68/108 (63.0)	54/109 (49.5)	0.046
PPS
Total number of patients	110	108
Primary outcome
Erosion improvement	69/110 (62.7)	54/108 (50.0)	0.058
Secondary outcome
Erosion cure	57/110 (51.8)	47/108 (43.5)	0.220
Bleeding improvement	24/33 (72.7)	26/35 (74.3)	0.884
Erythema improvement	33/79 (41.8)	41/80 (51.2)	0.231
Edema cure	20/31 (64.5)	16/23 (69.6)	0.697
Symptom improvement	71/110 (64.5)	61/108 (56.5)	0.223
Erosion improvement in symptomatic subjects1	64/102 (62.8)	51/104 (49.0)	0.048

¹For patients who responded to have symptoms, endoscopic erosion score improved by 50% or more.

Erosion improvement: The endoscopic erosion score improved by 50% or more. Erosion cure: No remaining erosions observed in endoscopy. Bleeding improvement: The endoscopic bleeding score improved by 50% or more in subjects with an initial bleeding score of 2 or higher. Erythema improvement: The endoscopic erythema score improved by 50% or in subjects with an initial erythema score of 2 or higher. Complete resolution of edema: No remaining edema observed in endoscopy. Symptom improvement: Symptom score improved by 50% or more. FAS: Full analysis set; PPS: Per-protocol set.