Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain (Dexilant)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01637571
Recruitment Status : Withdrawn (Sponsor could not fund)
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
University of Iowa

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.

Condition or disease Intervention/treatment Phase
Chest Pain Gastrointestinal Reflux Disease Drug: Dexilant Drug: Dexilant Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain GERD

Arm Intervention/treatment
Active Comparator: Dexilant
60mg of Dexilant QD for 12 weeks
Drug: Dexilant
60mg of Dexilant QD for 12 weeks

Placebo Comparator: Placebo
60mg of Dexilant placebo QD for 12 weeks
Drug: Dexilant Placebo
60mg of Dexilant placebo QD for 12 weeks
Other Name: Dexlansoprazole

Primary Outcome Measures :
  1. Frequency of chest pain episodes in treatment vs placebo groups [ Time Frame: 12 weeks ]
    the number of chest pain episodes during the study

Secondary Outcome Measures :
  1. Intensity of chest pain episodes [ Time Frame: 12 weeks ]
    how strong the chest pain episodes are

  2. Sensory thresholds for first sensation [ Time Frame: 12 weeks ]
    the balloon distension level when a sensation is first felt

  3. Sensory thresholds for discomfort [ Time Frame: 12 weeks ]
    the balloon distension level when discomfort is felt

  4. Sensory thresholds for pain [ Time Frame: 12 weeks ]
    the balloon distension level when pain is felt

  5. duration of chest pain episodes [ Time Frame: 12 weeks ]
    how long the chest pain episodes last

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged 18-75 years
  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:

  1. Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01637571

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Principal Investigator: Ron Schey, MD University of Iowa

Responsible Party: University of Iowa Identifier: NCT01637571     History of Changes
Other Study ID Numbers: 201102718
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012

Keywords provided by University of Iowa:
chest pain
GERD related non-cardiac chest pain

Additional relevant MeSH terms:
Gastroesophageal Reflux
Chest Pain
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action