Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
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ClinicalTrials.gov Identifier: NCT01129713 |
Recruitment Status
: Unknown
Verified August 2014 by Effexus Pharmaceutical.
Recruitment status was: Recruiting
First Posted
: May 25, 2010
Last Update Posted
: August 5, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Disease (GERD) Heartburn Indigestion | Drug: Secretol Drug: Nexium | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE). |
Study Start Date : | May 2010 |
Estimated Primary Completion Date : | May 2015 |
Estimated Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Nexium
Comparing 40 mg.once daily in healing erosive esophagitis.
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Drug: Nexium
Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.
Other Name: Esomeprazole
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Active Comparator: Secretol
Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.
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Drug: Secretol
Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.
Other Name: lansoprazole/omeprazole combination
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- Primary objective is to evaluate the relationship between healing and study drug allotment. [ Time Frame: 3 weeks of treatment ]The primary objective is to evaluate the relationship between healing and study drug allotment. The variables to be used are erosive esophagitis healing status after 3 weeks of treatment as assessed by EGD (upper endoscopy) comparing to base line EGD.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or Female
- Ages 18-75
- EE Los Angeles grades C or D
- Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
- Able to read, understand, and complete study questionnaires and record
- Able to understand the study procedures and sign informed consent
- Able to comply with all study requirements
Exclusion Criteria:
- Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Subjects with clinically significant underlying comorbidity
- Helicobacter pylori positive
- Clinically significant GI bleed within the last 3 months
- Esophagitis not related to acid reflux
- Bleeding disorder
- Zollinger-Ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy
- Women pregnant or lactating
- History of allergic reaction to any Proton Pump Inhibitor (PPI)
- Patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,NSAIDS > 3 times/week
- Any medication dependant on gastric acid for optimal absorption

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): NCT01129713
Contact: Ronnie Fass, MD | 520-792-1450 ext 5139 | ronnie.fass@va.gov | |
Contact: Marcia R. Willis, BS,CCRC | 520-792-1450 ext 2032 | marcia.willis@va.gov |
United States, Arizona | |
Southern Arizona Veterans Health Care System | Recruiting |
Tucson, Arizona, United States, 85723 | |
Principal Investigator: Ronnie Fass, MD |
Principal Investigator: | Ronnie Fass, MD | Southern Arizona VA Health Care System |
Responsible Party: | Effexus Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT01129713 History of Changes |
Other Study ID Numbers: |
NEXIUM versus SECRETOL |
First Posted: | May 25, 2010 Key Record Dates |
Last Update Posted: | August 5, 2014 |
Last Verified: | August 2014 |
Keywords provided by Effexus Pharmaceutical:
GERD Acid Reflux Heartburn Regurgitation Indigestion |
Additional relevant MeSH terms:
Gastroesophageal Reflux Heartburn Dyspepsia Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive |
Signs and Symptoms Esomeprazole Lansoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |