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

Primary Purpose

Chest Pain, Gastrointestinal Reflux Disease

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexilant
Dexilant Placebo
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring GERD, NCCP, chest pain, reflux, GERD related non-cardiac chest pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexilant

Placebo

Arm Description

60mg of Dexilant QD for 12 weeks

60mg of Dexilant placebo QD for 12 weeks

Outcomes

Primary Outcome Measures

Frequency of chest pain episodes in treatment vs placebo groups
the number of chest pain episodes during the study

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2011
Last Updated
July 10, 2012
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01637571
Brief Title
Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
Acronym
Dexilant
Official Title
The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor could not fund
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iowa

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Gastrointestinal Reflux Disease
Keywords
GERD, NCCP, chest pain, reflux, GERD related non-cardiac chest pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexilant
Arm Type
Active Comparator
Arm Description
60mg of Dexilant QD for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
60mg of Dexilant placebo QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dexilant
Intervention Description
60mg of Dexilant QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dexilant Placebo
Other Intervention Name(s)
Dexlansoprazole
Intervention Description
60mg of Dexilant placebo QD for 12 weeks
Primary Outcome Measure Information:
Title
Frequency of chest pain episodes in treatment vs placebo groups
Description
the number of chest pain episodes during the study
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intensity of chest pain episodes
Description
how strong the chest pain episodes are
Time Frame
12 weeks
Title
Sensory thresholds for first sensation
Description
the balloon distension level when a sensation is first felt
Time Frame
12 weeks
Title
Sensory thresholds for discomfort
Description
the balloon distension level when discomfort is felt
Time Frame
12 weeks
Title
Sensory thresholds for pain
Description
the balloon distension level when pain is felt
Time Frame
12 weeks
Title
duration of chest pain episodes
Description
how long the chest pain episodes last
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-75 years NERD, or GERD LA Class A-B (endoscopy) Subjects with positive pH testing At least one episode of chest pain a week in the past month Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram) Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia) Exclusion Criteria: Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy Subjects with previous upper gastrointestinal surgery Pregnancy Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric). Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm). Medications such as baclofen, and prokinetic agents. History of substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Schey, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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

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