Study Stopped
Sponsor could not fund
Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
Dexilant
The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP. 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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedJuly 11, 2012
July 1, 2012
December 6, 2011
July 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of chest pain episodes in treatment vs placebo groups
the number of chest pain episodes during the study
12 weeks
Secondary Outcomes (5)
Intensity of chest pain episodes
12 weeks
Sensory thresholds for first sensation
12 weeks
Sensory thresholds for discomfort
12 weeks
Sensory thresholds for pain
12 weeks
duration of chest pain episodes
12 weeks
Study Arms (2)
Dexilant
ACTIVE COMPARATOR60mg of Dexilant QD for 12 weeks
Placebo
PLACEBO COMPARATOR60mg of Dexilant placebo QD for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18-75 years
- NERD, or GERD LA Class A-B (endoscopy)
- Subjects with positive pH testing
- At least one episode of chest pain a week in the past month
- Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
- Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)
You may not qualify if:
- Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Pregnancy
- Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
- (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
- Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
- Medications such as baclofen, and prokinetic agents.
- History of substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Schey, MD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
July 11, 2012
Last Updated
July 11, 2012
Record last verified: 2012-07