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

Chest Pain Clinical Trial

— Dexilant  

Official title:

The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01637571
• Other study ID #: 201102718
• Status: Withdrawn
• Phase: Phase 4
• First received: December 6, 2011
• Last updated: July 10, 2012

Study information

• Verified date: July 2012
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Esophagitis, Peptic
• Gastrointestinal Reflux Disease

Intervention

Drug:
• Dexilant
60mg of Dexilant QD for 12 weeks
• Dexilant Placebo
60mg of Dexilant placebo QD for 12 weeks

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of chest pain episodes in treatment vs placebo groups	the number of chest pain episodes during the study	12 weeks	No
Secondary	Intensity of chest pain episodes	how strong the chest pain episodes are	12 weeks	No
Secondary	Sensory thresholds for first sensation	the balloon distension level when a sensation is first felt	12 weeks	No
Secondary	Sensory thresholds for discomfort	the balloon distension level when discomfort is felt	12 weeks	No
Secondary	Sensory thresholds for pain	the balloon distension level when pain is felt	12 weeks	No
Secondary	duration of chest pain episodes	how long the chest pain episodes last	12 weeks	No