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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Digestive & Liver Disease Specialists
ClinicalTrials.gov Identifier:
NCT00295685
First received: February 22, 2006
Last updated: February 24, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
GERD
Drug: Antacids
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Single Dose Nexium 40MG QAM vs Lansoprazole 30mg BID for Control of Symptomatic GERD-A Double Blind Cross-Over Study

Resource links provided by NLM:


Further study details as provided by Digestive & Liver Disease Specialists:

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

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295685

Locations
United States, Virginia
Digestive & Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Digestive & Liver Disease Specialists
AstraZeneca
Investigators
Principal Investigator: David A Johnson, MD Digestive & Liver Disease Specialists
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00295685     History of Changes
Other Study ID Numbers: IRUSESOM0159
Study First Received: February 22, 2006
Last Updated: February 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Digestive & Liver Disease Specialists:
Reflux
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014