DA-9601 for erosive gastritis: Results of a double-blind placebo-controlled phase III clinical trial

Table 1 Evaluation of efficacy based on endoscopic observa-tions

Score	Number of erosions
1 (none)	0
2 (mild)	1–2
3 (moderate)	3–5
4 (severe)	6 <

Table 2 Evaluation of efficacy in individual symptom

Score	Criteria
1 (none)	No symptom
2 (weak)	Symptoms occurred once a week
3 (moderate)	The symptoms did not affect their life and occurred more than twice a week
4 (strong)	The symptoms affected their everyday life and occurred daily

Table 3 Base-line characteristics of the patients (n, %)

Characteristic	DA-9601 180 mg (n = 186)	DA-9601 360 mg (n = 140)	Cetraxate 600 mg (n = 186)
Male sex	89 (47.9)	72 (51.4)	92 (49.5)
Age(yr)	45.9 ± 11.2	44.6 ± 12.1	46.4 ± 11.5
History < 1 wk	3 (1.6)	1 (0.7)	3 (1.6)
1–4 wk	31 (16.7)	28 (20.0)	29 (15.6)
> 4 wk	98 (52.7)	27 (19.3)	97 (52.2)
Unknown	54 (29.0)	84 (60.0)	57 (30.7)
Type Erosion	186 (100)	140 (100)	186 (100)
Bleeding	8 (4.3)	4 (2.9)	10 (5.4)
Redness	51 (27.4)	47 (33.6)	44 (23.7)
Edema	2 (1.1)	10 (7.1)	5 (2.7)
Grade Mild	14 (7.5)	18 (12.9)	21 (11.3)
Moderate	50 (26.9)	40 (28.6)	54 (29.0)
Severe	122 (65.6)	82 (58.6)	111 (59.7)

Data values are mean ± SD.

Table 4 Number of patients for ITT and PP assays

	Number of patients
	DA-9601 180 mg	DA-9601 360 mg	Cetraxate 600 mg
ITT analysis	186	140	186
PP analysis	171	120	166

Table 5 Incidence of adverse events (n, %)

	DA-9601 180 mg	Cetraxate 600 mg
Gastrointestinal
Dyspepsia	2 (1.08)	0
Nausea	2 (1.08)	0
Diarrhea	2 (1.08)	0
Heartburn	1 (0.54)	1 (0.54)
Abdominal pain	1 (0.54)	1 (0.54)
Acid reflux	0	1 (0.54)
Vomiting	1 (0.54)	1 (0.54)
CNS and ANS
Dizziness	1 (0.54)	0
Headache	1 (0.54)	1 (0.54)
Skin
Itching	1 (0.54)	1 (0.54)
Skin redness	1 (0.54)	1 (0.54)
Facial edema	0	1 (0.54)
Liver
sGPT elevation	1 (0.54)	1 (0.54)
sGOT elevation	0	1 (0.54)
Bilirubin elevation	0	1 (0.54)
Total	14 (7.53)	11 (5.91)