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Clinical Trials

Protonix (pantoprazole sodium) Delayed Release Tablets

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved April 2002

Specific Treatments:

Gastroesophageal disorders

General Information

Protonix is an acid suppressant originally approved in February 2000 for the short-term treatment, of up to eight weeks, and symptomatic relief of erosive esophagitis (EE) associated with gastroesophageal reflux disease (GERD). In June 2001 Protonix Delayed Release Tablets were additionally approved for the maintenance of healing of EE and daytime and nighttime control of heartburn associated with GERD. The indication was further expanded in April 2002 with Protonix's approval for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

Esophagitis may be caused by irritation of the esophagus due to acid reflux from the stomach to the esophagus. Although 36% of healthy Americans experience this sort of reflux at least once a month, up to 10% of suffer from GERD on a daily basis. EE can be a precursor to more serious esophageal diseases.

Zollinger-Ellison Syndrome is a rare and potentially deadly disease that typically affects those between the ages of 30 and 50. It is caused by a neuroendocrine tumor, called a gastrinoma, located in the pancreas or duodenum. Due to the tumor, high levels of gastrin are circulated, which results in excessive levels of gastric acid secretion and leads to severe ulceration of the upper gastrointestinal tract. Such lack of control over acid levels may lead to serious complications.

Clinical Results

The approval Protonix for the treatment of EE associated with GERD is supported by two double-blind, placebo-controlled dose escalating studies with approximately 850 subjects with reflux symptoms and endoscopically diagnosed EE. All three dosages used yielded significantly better healing rates than placebo, with the 40 mg dose proving most effective. Subjects in that group experienced complete cessation of heartburn and consumed significantly fewer antacid tablets per day starting on the first day of treatment.

Two randomized, double-blind, comparator-controlled trials were conducted in 790 GERD subjects with endoscopically-confirmed healed EE, to determine the effectiveness of Protonix in long-term maintenance of healing. Protonix 40 mg was significantly superior to the comparator at every time point for the maintenance of healing and for reduction in daytime and nighttime heartburn episodes.

Protonix's approval for the treatment of Zollinger-Ellison Syndrome is based on a multi-center trial with 35 subjects with Zollinger-Ellison Syndrome or another hypersecretory condition. Results showed that acid output was controlled for most subjects for up to six months and that at six months, 94% of subjects had responded to treatment.

Side Effects

Adverse events associated with the use of Protonix (pantoprazole) may include (but are not limited to) the following:

  • Diarrhea
  • Rash
  • Abdominal pain
  • Flatulence
  • Nausea
  • Vomiting

Mechanism of Action

Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by forming a covalent bond to two sites of the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours. (From FDA Label)

Additional Information

For additional information on Protonix Delayed Release Tablets, please visit Protonix.

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