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Table 2 Demographic and baseline disease characteristics of all patients enrolled (N = 109)

From: Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study

 

Children < 20 kg

Children ≥ 20 kg

Characteristic

Esomeprazole

5 mg

(0.3-0.6 mg/kg)

(n = 26)

Esomeprazole

10 mg

(0.6-1.0 mg/kg)

(n = 23)

Esomeprazole

10 mg

(0.2-0.5 mg/kg)

(n = 31)

Esomeprazole

20 mg

(0.3-1.0 mg/kg)

(n = 29)

Girls, n (%)

14 (53.8)

14 (60.9)

14 (45.2)

11 (37.9)

Mean age, years

2.1

2.5

8.5

8.3

Age in years, n (%)

    

   1

12 (46.2)

8 (34.8)

  

   2

6 (23.1)

5 (21.7)

  

   3

4 (15.4)

4 (17.4)

  

   4

2 (7.7)

3 (13.0)

1 (3.2)

2 (6.9)

   5

1 (3.8)

2 (8.7)

1 (3.2)

1 (3.4)

   6

1 (3.8)

1 (4.3)

2 (6.5)

0

   7

  

5 (16.1)

3 (10.3)

   8

  

5 (16.1)

9 (31.0)

   9

  

8 (25.8)

6 (20.7)

   10

  

3 (9.7)

6 (20.7)

   11

  

6 (19.4)

2 (6.9)

Race, n (%)

    

   White

19 (73.1)

19 (82.6)

26 (83.9)

25 (86.2)

   Black

7 (26.9)

4 (17.4)

5 (16.1)

3 (10.3)

   Other

0

0

0

1 (3.4)

Mean height (range), cm

90.0 (70-109)

94.2 (80-119)

134.5 (108-168)

134.5 (112-159)

Mean weight (range), kg

12.8 (8-18)

14.1 (10-18)

35.5 (20-58)

34.5 (21-60)

Mean body mass index (SD), kg/m2

15.7 (2.1)

15.9 (1.7)

19.3 (4.8)

18.6 (3.9)

Helicobacter pylori-positive, n (%)

0

1 (4.3)

0

0

Symptoms at baseline, n (%)

    

   Heartburn

15 (57.7)

10 (43.5)

19 (61.3)

13 (44.8)

   Acid regurgitation

18 (69.2)

11 (47.8)

20 (64.5)

11 (37.9)

   Epigastric pain

17 (65.4)

13 (56.5)

15 (48.4)

15 (51.7)

   Vomiting

13 (50.0)

7 (30.4)

3 (9.7)

5 (17.2)

   Eating difficulties

15 (57.7)

13 (56.5)

9 (29.0)

7 (24.1)

   Difficulty swallowing

6 (23.1)

8 (34.8)

5 (16.1)

6 (20.1)

Extraesophageal symptoms at baseline, n (%)

n = 12

n = 12

n = 16

n = 13

   Hoarseness

4 (33.3)

4 (50.0)

4 (25.0)

7 (53.8)

   Coughing

8 (66.7)

9 (75.0)

7 (43.8)

7 (53.8)

   Gagging

5 (41.7)

6 (50.0)

2 (12.5)

4 (30.8)

   Wheezing/stridor

1 (8.3)

1 (8.3)

2 (12.5)

0 (0)

Mean (range) esomeprazole dose, mg/kg

0.4 (0.3-0.6)

0.7 (0.6-1.0)

0.3 (0.2-0.5)

0.6 (0.3-1.0)