Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients … (NCT01129713) | Clinical Trial Compass
UnknownPhase 1/2
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
United States40 participantsStarted 2010-05
Plain-language summary
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Primary objective is to evaluate the relationship between healing and study drug allotment.