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

This study has been withdrawn prior to enrollment.
(Sponsor could not fund)
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01637571
First received: December 6, 2011
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Chest Pain
Gastrointestinal Reflux Disease
 Drug: Dexilant
Drug: Dexilant Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Frequency of chest pain episodes in treatment vs placebo groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    the number of chest pain episodes during the study


Secondary Outcome Measures:
  • Intensity of chest pain episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    how strong the chest pain episodes are

  • Sensory thresholds for first sensation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    the balloon distension level when a sensation is first felt

  • Sensory thresholds for discomfort [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    the balloon distension level when discomfort is felt

  • Sensory thresholds for pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    the balloon distension level when pain is felt

  • duration of chest pain episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    how long the chest pain episodes last


Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637571

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

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01637571     History of Changes
Other Study ID Numbers: 201102718
Study First Received: December 6, 2011
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Chest Pain
Gastroesophageal Reflux
Esophagitis, Peptic
Pain
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
 Gastroenteritis
Peptic Ulcer
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013