Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
NCT ID: NCT01637571
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
Brief Summary
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The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dexilant
60mg of Dexilant QD for 12 weeks
Dexilant
60mg of Dexilant QD for 12 weeks
Placebo
60mg of Dexilant placebo QD for 12 weeks
Dexilant Placebo
60mg of Dexilant placebo QD for 12 weeks
Interventions
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Dexilant
60mg of Dexilant QD for 12 weeks
Dexilant Placebo
60mg of Dexilant placebo QD for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. NERD, or GERD LA Class A-B (endoscopy)
3. Subjects with positive pH testing
4. At least one episode of chest pain a week in the past month
5. Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
6. Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)
Exclusion Criteria
2. Subjects with previous upper gastrointestinal surgery
3. Pregnancy
4. Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
5. (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
6. Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
7. Medications such as baclofen, and prokinetic agents.
8. History of substance abuse
18 Years
75 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Responsible Party
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Principal Investigators
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Ron Schey, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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Other Identifiers
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201102718
Identifier Type: -
Identifier Source: org_study_id