Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD) - NCT00658528-11501 (Clinical Trial 215167)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy215167.aspx
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| City: |
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Mineola |
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State:
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NY |
| Zip Code: |
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11501 |
| Conditions: |
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Gastroesophageal Reflux Disease (GERD) |
| Purpose: |
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The purpose of this study is to determine the safety and efficacy of Rabeprazole extended
release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among
subjects with erosive gastroesophageal reflux disease (GERD).
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| Study summary: |
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This is a multicenter, randomized, double-blind, double-dummy, parallel-group study.
Subjects who meet all of the inclusion/exclusion criteria will be randomly assigned to 1 of
2 treatment groups, RAB ER 50 mg or ESO 40 mg for the treatment of moderate to severe
erosive GERD. |
| Criteria: |
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KEY INCLUSION CRITERIA:
1. Male or female, ages 18 to 75 years.
2. History of GERD symptoms for at least 3 months immediately before screening.
3. Heartburn for at least 2 days a week for at least 1 month before screening.
4. Esophageal erosions of Los Angeles (LA) grades C or D based on EGD taken within 14
days prior to enrollment.
5. Subjects who are H. pylori negative based on a screening test.
6. Females should be either of non-childbearing potential or of childbearing potential.
Females of childbearing potential must have negative pregnancy tests prior to
randomization. Female subjects of childbearing potential must agree to use medically
acceptable methods of contraception.
7. Subjects must be able to read, write, and understand the language of the symptom
diary.
KEY EXCLUSION CRITERIA:
1. Current or a history of esophageal motility disorders.
2. Current or a history of Barrett's esophagus. Current esophageal strictures or
esophagitis (known or suspected to be due to etiology other than GERD such as
infection or medications).
3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory
conditions, or current gastric or duodenal ulcer.
4. Current or a history of cancer, with the exception of fully excised skin basal cell
carcinoma.
5. Inflammatory bowel disease.
6. Unstable diabetes mellitus.
7. History of esophageal, gastric and duodenal surgery except simple suturing of an
ulcer.
8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral
steroids (>= 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day). |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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