Lansoprazole (Page 9 of 14)

14 CLINICAL STUDIES

14.1 Duodenal Ulcer

In a US multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of lansoprazole once daily) study of 284 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after two and four weeks was significantly higher with all doses of lansoprazole than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with lansoprazole 15 mg. Based on this study and the second study described below, the recommended dose of lansoprazole in duodenal ulcer is 15 mg per day (Table 9).

Table 9. Duodenal Ulcer Healing Rates
Week Lansoprazole Placebo (N=72)
15 mg daily (N=68) 30 mg daily (N=74) 60 mg daily (N=70)
2 42.4% * 35.6% * 39.1% * 11.3%
4 89.4% * 91.7% * 89.9% * 46.1%

* (p≤0.001) vs placebo.

Lansoprazole 15 mg was significantly more effective than placebo in relieving day and nighttime abdominal pain and in decreasing the amount of antacid taken per day.

In a second US multicenter study, also double-blind, placebo-controlled, dose- comparison (15 and 30 mg of lansoprazole once daily), and including a comparison with ranitidine, in 280 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after four weeks was significantly higher with both doses of lansoprazole than with placebo. There was no evidence of a greater or earlier response with the higher dose of lansoprazole. Although the 15 mg dose of lansoprazole was superior to ranitidine at four weeks, the lack of significant difference at two weeks and the absence of a difference between 30 mg of lansoprazole and ranitidine leaves the comparative effectiveness of the two agents undetermined (Table 10) [see Indications and Usage ( 1.1)].

Table 10. Duodenal Ulcer Healing Rates
Week Lansoprazole Ranitidine Placebo (N=41)
15 mg daily (N=80) 30 mg daily (N=77) 300 mg h.s (N=82)
2 35.0% 44.2% 30.5% 34.2%
4 92.3% * 80.3% 70.5% 47.5%

* (p ≤ 0.05) vs placebo and ranitidine. (p ≤ 0.05) vs placebo

14.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence

Randomized, double-blind clinical studies performed in the US in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) evaluated the efficacy of lansoprazole in combination with amoxicillin and clarithromycin as triple 14 day therapy or in combination with amoxicillin as dual 14 day therapy for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of two different eradication regimens were established:

Triple therapy: Lansoprazole 30 mg twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily

Dual therapy: Lansoprazole 30 mg three times daily/amoxicillin 1 g three times daily

All treatments were for 14 days. H. pylori eradication was defined as two negative tests (culture and histology) at four to six weeks following the end of treatment.
Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. A randomized, double-blind clinical study performed in the US in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) compared the efficacy of lansoprazole triple therapy for 10 and 14 days. This study established that the 10 day triple therapy was equivalent to the 14 day triple therapy in eradicating H. pylori ( Tables 11 and 12) [see Indications and Usage ( 1.2)] .

Table 11. H. pylori Eradication Rates – Triple Therapy (Lansoprazole/amoxicillin/clarithromycin) Percent of Patients Cured [95% Confidence Interval] (Number of patients)
Study Duration Triple Therapy Evaluable Analysis * Triple Therapy Intent-to-Treat Analysis
M93-131 14 days 92 [80.0-97.7] (N=48) 86 [73.3-93.5] (N=55)
M95-392 14 days 86 § [75.7-93.6] (N=66) 83 § [72.0-90.8] (N=70)
M95-399 14 days 85 [77-91.0] (N=113) 82 [73.9-88.1] (N=126)
10 days 84 [76.0-89.8] (N=123) 81 [73.9-87.6] (N=135)

*Based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest, histology and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the evaluable analysis as failures of therapy.
Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within one year). All dropouts were included as failures of therapy.
(p<0.05) vs lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.
§ (p<0.05) vs clarithromycin/amoxicillin dual therapy. The 95% confidence interval for the difference in eradication rates, 10 day minus 14 day is (-10.5, 8.1) in the evaluable analysis and (-9.7, 9.1) in the intent-to-treat analysis.

Table 12. H. pylori Eradication Rates – 14 Day Dual Therapy (Lansoprazole/amoxicillin) Percent of Patients Cured [95% Confidence Interval] (Number of patients)
Study Dual Therapy Evaluable Analysis * Dual Therapy Intent-to-Treat Analysis
M93-131 77 [62.5-87.2] (N=51) 70 [56.8-81.2] (N=60)
M93-125 66 § [51.9-77.5] (N=58) 61 § [48.5-72.9] (N=67)


Based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest, histology and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.
Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within one year). All dropouts were included as failures of therapy.
(p<0.05) vs lansoprazole alone. § (p<0.05) vs lansoprazole alone or amoxicillin alone.

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