Dexilant Treatment in Gastrointestinal Reflux Disease (GE... | NCT01637571

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

NCT01637571

Sponsor

University of Iowa

Status

Withdrawn

Last Update Posted

Jul 11, 2012Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Chest Pain
Gastrointestinal Reflux Disease

Interventions

Dexilant
Dexilant Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor could not fund

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 6, 2011

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2012

Last Update Posted Date

Jul 11, 2012Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexilant	Active Comparator	60mg of Dexilant QD for 12 weeks	Drug: Dexilant
Placebo	Placebo Comparator	60mg of Dexilant placebo QD for 12 weeks	Drug: Dexilant Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexilant	Drug	60mg of Dexilant QD for 12 weeks	Dexilant
Dexilant Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of chest pain episodes in treatment vs placebo groups	the number of chest pain episodes during the study	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Intensity of chest pain episodes	how strong the chest pain episodes are	12 weeks
Sensory thresholds for first sensation	the balloon distension level when a sensation is first felt

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Schey, MD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Hospitals and Clinics		Iowa City	Iowa	52242	United States

Condition Browse Module

MeSH Terms

ID	Term
D002637	Chest Pain
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064748	Dexlansoprazole

Ancestor Terms

ID	Term
D064747	Lansoprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided