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

This study is currently recruiting participants.
Verified by Digestive & Liver Disease Specialists, February 2006

Sponsors and Collaborators: Digestive & Liver Disease Specialists
AstraZeneca
Information provided by: Digestive & Liver Disease Specialists
ClinicalTrials.gov Identifier: NCT00295685
  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 IV

Drug Information available for:   Esomeprazole magnesium    Esomeprazole Sodium    Omeprazole    Omeprazole magnesium    Lansoprazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Single Dose Nexium 40MG QAM Vs Lansoprazole 30mg BID for Control of Symptomatic GERD-A Double Blind Cross-Over Study

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:   July 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

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

Contacts
Contact: Diana B Sheldon, LPN     757-466-0165 ext 110     dianas@dlds.org    
Contact: Pamela K Hoisington, BS     757-466-0165 ext 126     pamelah@dlds.org    

Locations
United States, Virginia
Digestive & Liver Disease Specialists     Recruiting
      Norfolk, Virginia, United States, 23502
      Principal Investigator: David A Johnson, MD            

Sponsors and Collaborators
Digestive & Liver Disease Specialists
AstraZeneca

Investigators
Principal Investigator:     David A Johnson, MD     Digestive & Liver Disease Specialists    
  More Information


Study ID Numbers:   IRUSESOM0159
First Received:   February 22, 2006
Last Updated:   May 19, 2006
ClinicalTrials.gov Identifier:   NCT00295685
Health Authority:   United States: Food and Drug Administration

Keywords provided by Digestive & Liver Disease Specialists:
Reflux  
GERD  

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on October 29, 2008




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