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

Phase 4

Withdrawn

• Conditions: Chest Pain; Gastrointestinal Reflux Disease
• Interventions: Drug: Dexilant; Drug: Dexilant Placebo

• Registration Number: NCT01637571
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-06
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexilant	Dexilant	60mg of Dexilant QD for 12 weeks
Placebo	Dexilant Placebo	60mg of Dexilant placebo QD for 12 weeks

Primary Outcome Measures

Name	Time	Method
Frequency of chest pain episodes in treatment vs placebo groups	12 weeks	the number of chest pain episodes during the study

Secondary Outcome Measures

Name	Time	Method
Intensity of chest pain episodes	12 weeks	how strong the chest pain episodes are
Sensory thresholds for first sensation	12 weeks	the balloon distension level when a sensation is first felt
Sensory thresholds for discomfort	12 weeks	the balloon distension level when discomfort is felt
Sensory thresholds for pain	12 weeks	the balloon distension level when pain is felt
duration of chest pain episodes	12 weeks	how long the chest pain episodes last

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States