Skip to main content
OpenTrials
Completed

NCT Number: NCT00204373

Treatment of Zollinger-Ellison Syndrome With Prevacid

The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Zollinger-Ellison Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Multiple Endocrine Neoplasia Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Peptic Ulcer Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observation of the efficacy in controlling gastric acid production and of the safety of high dose, long-term use of Prevacid.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with Zollinger-Ellison syndrome

Exclusion criteria

  • Pregnant or lactating females

Treatment and study plan

Lansoprazole (Prevacid)

Drug

Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.

Other names: Lansoprazole is marketed as Prevacid.

Primary outcomes

  1. Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.

    Time frame: up to 240 months from study enrollment

    number of participants with control of gastric acid production

Secondary outcomes

  1. The Median Survival From the Time of Diagnosis.

    Time frame: survival or up to 240 months

    The median survival from the time of diagnosis

Sponsors and collaborators

Lead sponsor

Charles Mel Wilcox, MD

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Oct 30, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.