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

University of Iowa

Status and phase: Withdrawn; Phase 4

Conditions: Gastrointestinal Reflux Disease; Chest Pain

Treatments: Drug: Dexilant; Drug: Dexilant Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01637571

201102718

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Dexilant

Active Comparator group

Description:

60mg of Dexilant QD for 12 weeks

Treatment:

Drug: Dexilant

Placebo

Placebo Comparator group

Description:

60mg of Dexilant placebo QD for 12 weeks

Treatment:

Drug: Dexilant Placebo