Study 2 was a single-center, double-blind, parallel-group study to compare the clinical effects of PROTONIX I.V. for Injection and oral PROTONIX. Patients (n=45, median age 56 years, 21 males and 24 females) with acute endoscopically proven reflux esophagitis (Savary/Miller Stage II or III) with at least 1 of 3 symptoms typical for reflux esophagitis (acid eructation, heartburn, or pain on swallowing) were randomized to receive either 40 mg intravenous pantoprazole or 40 mg oral pantoprazole daily for 5 days. After the initial 5 days, all patients were treated with 40 mg oral pantoprazole daily to complete a total of 8 weeks of treatment. Symptom relief was assessed by calculating the daily mean of the sums of the average scores for these 3 symptoms and the daily mean of the average score for each of the symptoms separately. There was no significant difference in symptom relief between PROTONIX I.V. and oral PROTONIX therapy within the first 5 days. A repeat endoscopy after 8 weeks of treatment revealed that 20 out of 23 (87%) of the PROTONIX I.V. plus oral PROTONIX patients and 19 out of 22 (86%) of the oral PROTONIX patients had endoscopically proven healing of their esophageal lesions.

Data comparing PROTONIX I.V. for Injection to other proton pump inhibitors (oral or I.V.) or H2 receptor antagonists (oral or I.V.) are limited, and therefore, are inadequate to support any conclusions regarding comparative efficacy.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome Two studies measured the pharmacodynamic effects of 6 day treatment with PROTONIX I.V. for Injection in patients with Zollinger-Ellison Syndrome (with and without multiple endocrine neoplasia type I). In one of these studies, an initial treatment with PROTONIX I.V. for Injection in 21 patients (29 to 75 years; 8 female; 4 black, 1 Hispanic, 16 white) reduced acid output to the target level ( ≤ 10 mEq/h) and significantly reduced H+ concentration and the volume of gastric secretions; target levels were achieved within 45 minutes of drug administration.

In the other study of 14 patients (38 to 67 years; 5 female; 2 black, 12 white) with Zollinger- Ellison Syndrome, treatment was switched from an oral proton pump inhibitor to PROTONIX I.V. for Injection. PROTONIX I.V. for Injection maintained or improved control of gastric acid secretion.

In both studies, PROTONIX I.V. for Injection 160 or 240 mg per day in divided doses maintained basal acid secretion below target levels in all patients. Target levels were 10 mEq/h in patients without prior gastric surgery, and 5 mEq/h in all patients with prior gastric acid- reducing surgery. Once gastric acid secretion was controlled, there was no evidence of tolerance during this 7 day study. Basal acid secretion was maintained below target levels for at least 24 hours in all patients and through the end of treatment in these studies (3 to 7 days) in all but 1 patient who required a dose adjustment guided by acid output measurements until acid control was achieved. In both studies, doses were adjusted to the individual patient need, but gastric acid secretion was controlled in greater than 80% of patients by a starting regimen of 80 mg q12h.

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