Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00295685 |
Recruitment Status
:
Completed
First Posted
: February 24, 2006
Last Update Posted
: February 25, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
GERD | Drug: Antacids | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
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 |
Study Start Date : | October 2005 |
Study Completion Date : | December 2007 |
- 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.
- Changes in GERD symptom scores, health related quality of life, ancillary medication expenditures, and predictors of successful step-down.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295685
United States, Virginia | |
Digestive & Liver Disease Specialists | |
Norfolk, Virginia, United States, 23502 |
Principal Investigator: | David A Johnson, MD | Digestive & Liver Disease Specialists |
ClinicalTrials.gov Identifier: | NCT00295685 History of Changes |
Other Study ID Numbers: |
IRUSESOM0159 |
First Posted: | February 24, 2006 Key Record Dates |
Last Update Posted: | February 25, 2009 |
Last Verified: | February 2009 |
Keywords provided by Digestive & Liver Disease Specialists:
Reflux GERD |
Additional relevant MeSH terms:
Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |