Table 13

H. pylori Eradication Rates at 4 Weeks after 10 Day Treatment Regimen % of Patients Cured [95% Confidence Interval] (Number of Patients) *
Patients were included in the analysis if they had H. pylori infection documented at baseline, had at least one endoscopically verified duodenal ulcer ≥ 0.5 cm in diameter at baseline or had a documented history of duodenal ulcer disease within the past 5 years, and were not protocol violators. Patients who dropped out of the study due to an adverse reaction related to the study drug were included in the analysis as not H. pylori eradicated.
†
Patients were included in the analysis if they had documented H. pylori infection at baseline, had at least one documented duodenal ulcer at baseline, or had a documented history of duodenal ulcer disease, and took at least one dose of study medication. All dropouts were included as not H. pylori eradicated.
‡
p < 0.05 compared to NEXIUM plus clarithromycin
§
p < 0.05 compared to NEXIUM alone
Study
 Treatment Group
 Per-Protocol *
 Intent-to-Treat †
 
191
 NEXIUM plus amoxicillin and clarithromycin
 84%‡

[78, 89]

(n=196)
 77%‡
191
 NEXIUM plus amoxicillin and clarithromycin
 84%‡

[78, 89]

(n=196)
 77%‡

[71, 82]

(n=233)
 
 NEXIUM plus clarithromycin
 55%

[48, 62]

(n=187)
 52%

[45, 59]

(n=215)
 
193
 NEXIUM plus amoxicillin and clarithromycin
 85%§

[74, 93]

(n=67)
 78%§

[67, 87]

(n=74)
 
 NEXIUM
 5%

[0, 23]

(n=22)
 4%

[0, 21]

(n=24)
Patients were included in the analysis if they had H. pylori infection documented at baseline, had at least one endoscopically verified duodenal ulcer ≥ 0.5 cm in diameter at baseline or had a documented history of duodenal ulcer disease within the past 5 years, and were not protocol violators. Patients who dropped out of the study due to an adverse reaction related to the study drug were included in the analysis as not H. pylori eradicated.
†
Patients were included in the analysis if they had documented H. pylori infection at baseline, had at least one documented duodenal ulcer at baseline, or had a documented history of duodenal ulcer disease, and took at least one dose of study medication. All dropouts were included as not H. pylori eradicated.
‡
p < 0.05 compared to NEXIUM plus clarithromycin
§
p < 0.05 compared to NEXIUM alone

The percentage of patients with a healed baseline duodenal ulcer by 4 weeks after the 10 day treatment regimen in the NEXIUM plus amoxicillin and clarithromycin group was 75% (n=156) and 57% (n=60) respectively, in the 191 and 193 studies (per-protocol analysis).

14.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
In a multicenter, open-label dose-escalation study of 21 patients (15 males and 6 females, 18 Caucasian and 3 Black, mean age of 55.5 years) with pathological hyp