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Table 2 Healing rate of erosive esophagitis by weeks 8 and 4

From: 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

 

Complete healing of EE

Difference (%) from HGP1705 40 mg

95% CI on the difference

P-value*

PPS by week 8

    

 HIP1601 (n = 93)

91 (97.8%)

1.0

-4.7, 7.2

< 0.001

 HGP1705 (n = 94)

91 (96.8%)

   

FAS by week 8

    

 HIP1601 (n = 103)

101 (98.1%)

3.1

-2.5, 9.7

< 0.001

 HGP1705 (n = 100)

95 (95.0%)

   

PPS at week 4

    

 HIP1601 (n = 93)

85 (91.4%)

-1.2

-8.9, 6.6

0.013

 HGP1705 (n = 94)

87 (92.6%)

   

FAS at week 4

    

 HIP1601 (n = 103)

95 (92.2%)

3.2

-4.8, 11.3

0.001

 HGP1705 (n = 100)

89 (89.0%)

   
  1. EE, erosive esophagitis; CI, confidence interval; FAS, full analysis set; PPS, per protocol set
  2. * P-value for the non-inferiority test with a margin − 10%