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OpenTrials
Completed

NCT Number: NCT00079833

Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome

This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.

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Key information

Conditions

Zollinger-Ellison Syndrome Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Neoplasms Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Clichy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females at least 18 years of age.
  • Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion

Exclusion criteria

  • Pregnant or lactating females
  • History of drug addiction or alcohol abuse within 12 months prior to Screening.
  • History of intolerance to any proton pump inhibitors or any ingredient in their formulation.

Treatment and study plan

Esomeprazole magnesium (Nexium)

Drug

Primary outcomes

  1. To assess the gastric acid secretory rate at the final study visit.

  2. Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery

Secondary outcomes

  1. The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.

  2. Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery.

  3. The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months

Important dates

Study start
2003
Study completion
2005
First posted
Mar 17, 2004
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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