Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD

February 24, 2009 updated by: Digestive & Liver Disease Specialists

Single Dose Nexium 40MG QAM vs Lansoprazole 30mg BID for Control of Symptomatic GERD-A Double Blind Cross-Over Study

The purpose of this study is to determine if people taking lansoprazole two times a day to control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium just once a day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

approximately 20% of patients taking first generation proton pump inhibitors (PPIs) are taking more than the standard approved dose. This dosing is required to attain adequate control of the gastric and intraesophageal pH in order to affect the desired clinical improvement. It is recognized that the b.i.d dosing strategy increases the intragastric pH control of <4 from approximately 12 hours to almost 16 hours. The refinement of the S isomer of omeprazole (Nexium)has led to a way to more effectively control acid exposure. Comparative trials with all the PPIs have shown significantly greater pH control of <4 and head to head comparisons as well as a recent crossover study. One study suggests that Nexium dosing contains approximately 16.5 hours of a pH control of <4. Conceivably, this duration of pH control suggests that b.i.d. dosing of other PPIs might be avoided. Furthermore, it suggests that patients currently taking b.i.d. PPIs might be successful candidates for conversion to q.d. Nexium. This would provide a considerable cost implication to health care plans and for patients who are responsible for paying for their PPI therapy. To date, esomeprazole has not been studied in comparison to b.i.d. dosing with other PPIs. There is pharmacologic evidence to suggest, however, that it is comparable. In this proposed study, we believe that by beginning with patients who were well controlled should make for a cleaner definition and a higher likelihood to demonstrate efficacy.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive & Liver Disease Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous diagnosis of severe GERD.
  • Male or female 18-80 years of age
  • Ability to read, understand and provide informed consent
  • GERD is Adequately controlled on BID lansoprazole as evidenced by GERD-HRQL score of </= 11
  • Females of childbearing potential must use an acceptable method of birth control for the duration of the study.

Exclusion Criteria:

  • Known contraindications to Nexium
  • Current or historical evidence of >3 cm histologically confirmed Barrett's metaplasia without current dysplasia, esophageal stricture or extraesophageal GERD symptoms.
  • Previous Esophageal gastric surgery
  • Pregnant or nursing Females
  • Clinically significant abnormal laboratory values
  • Medical condition that may be adversely impacted by participation in this study
  • History of or current drug or alcohol abuse
  • Known malignancy
  • Need for concurrent therapy with any acid suppressive therapy other than the study drug, antacids, alginates, NSAIDS, >165 mg ASA, prostaglandin analogs, prokinetic drug, antineoplastic agents, Ketoconazole, Itraconazole, Voriconazole, Clarithromycin, Telithromycin, HIV protease inhibitors, Rifampin, Phenobarbital, or Digoxin
  • Use of investigational drug or experimental device within 30 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The proportion of subjects who are successfully stepped-down to single-dose PPI therapy, defined as having no recurrence of heartburn or acid regurgitation 3 months after PPI step-down.

Secondary Outcome Measures

Outcome Measure
Changes in GERD symptom scores, health related quality of life, ancillary medication expenditures, and predictors of successful step-down.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Digestive & Liver Disease Specialists

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (ESTIMATE)

February 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSESOM0159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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