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This study has been withdrawn prior to enrollment.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

December 6, 2011
July 10, 2012
Not Provided
Not Provided
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
Same as current
Complete list of historical versions of study NCT01637571 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Chest Pain
  • Gastrointestinal Reflux Disease
  • Drug: Dexilant
    60mg of Dexilant QD for 12 weeks
  • Drug: Dexilant Placebo
    60mg of Dexilant placebo QD for 12 weeks
    Other Name: Dexlansoprazole
  • Active Comparator: Dexilant
    60mg of Dexilant QD for 12 weeks
    Intervention: Drug: Dexilant
  • Placebo Comparator: Placebo
    60mg of Dexilant placebo QD for 12 weeks
    Intervention: Drug: Dexilant Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01637571
201102718
Not Provided
University of Iowa
University of Iowa
Not Provided
Principal Investigator: Ron Schey, MD University of Iowa
University of Iowa
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP