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Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexlansoprazole MR
Dexlansoprazole MR
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis. Exclusion Criteria: Any condition that may require inpatient surgery during the course of the study. Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study. Use of antacids [except for study supplied Gelusil®]. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study. Evidence of uncontrolled systemic disease. Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid. Need to take blood thinners. Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month. Had cancer (except basal cell cancer of the skin) within 3 years prior to screening. Has other esophageal disease including Barrett's esophagus or strictures requiring dilation. Has had radiation or cryotherapy to the esophagus. Has active gastric or duodenal ulcers within 4 weeks of starting study drug. Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome. History of alcohol abuse. Has acquired immunodeficiency syndrome. Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy. Received a blood product transfusion within 3 months of taking the first dose of study drug. Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dexlansoprazole MR 60 mg QD

Dexlansoprazole MR 90 mg QD

Arm Description

Outcomes

Primary Outcome Measures

Mean Change From Baseline to Month 12 for Hemoglobin Values
Mean Change From Baseline to Month 12 for Hematocrit Values
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
Mean Change From Baseline to Month 12 for Platelet Count Values
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
Mean Change From Baseline to Month 12 for Creatinine Values
Mean Change From Baseline to Month 12 for Calcium Values
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
Mean Change From Baseline to Month 12 for Total Bilirubin Values
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
Mean Change From Baseline to Month 12 for Pulse Rate
Changes From Baseline to Final Visit in Antrum Biopsy Results
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Changes From Baseline to Final Visit in Fundus Biopsy Results
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.

Secondary Outcome Measures

Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

Full Information

First Posted
November 15, 2005
Last Updated
June 27, 2016
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00255190
Brief Title
Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Official Title
A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Detailed Description
This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions. Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study. After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months. Approximately 200 study sites in the U.S. will participate. For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
591 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexlansoprazole MR 60 mg QD
Arm Type
Experimental
Arm Title
Dexlansoprazole MR 90 mg QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole MR
Other Intervention Name(s)
TAK-390MR, Kapidex, Dexilant
Intervention Description
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole MR
Other Intervention Name(s)
TAK-390MR, Kapidex, Dexilant
Intervention Description
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Month 12 for Hemoglobin Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Hematocrit Values
Description
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Platelet Count Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Creatinine Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Calcium Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Total Bilirubin Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 12 for Pulse Rate
Time Frame
Baseline and Month 12
Title
Changes From Baseline to Final Visit in Antrum Biopsy Results
Description
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Time Frame
Baseline and Final Visit (up to 12 months)
Title
Changes From Baseline to Final Visit in Fundus Biopsy Results
Description
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Time Frame
Baseline and Final Visit (up to 12 months)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
Description
Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time Frame
Baseline and Month 1
Title
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
Description
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time Frame
Baseline and Month 3
Title
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
Description
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time Frame
Baseline and Month 6
Title
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
Description
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time Frame
Baseline and Month 9
Title
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
Description
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time Frame
Baseline and Month 12
Title
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
Description
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time Frame
Baseline and Month 1
Title
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
Description
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time Frame
Baseline and Month 3
Title
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
Description
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time Frame
Baseline and Month 6
Title
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
Description
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time Frame
Baseline and Month 9
Title
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
Description
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time Frame
Baseline and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis. Exclusion Criteria: Any condition that may require inpatient surgery during the course of the study. Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study. Use of antacids [except for study supplied Gelusil®]. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study. Evidence of uncontrolled systemic disease. Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid. Need to take blood thinners. Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month. Had cancer (except basal cell cancer of the skin) within 3 years prior to screening. Has other esophageal disease including Barrett's esophagus or strictures requiring dilation. Has had radiation or cryotherapy to the esophagus. Has active gastric or duodenal ulcers within 4 weeks of starting study drug. Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome. History of alcohol abuse. Has acquired immunodeficiency syndrome. Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy. Received a blood product transfusion within 3 months of taking the first dose of study drug. Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Alabaster
State/Province
Alabama
Country
United States
City
Anniston
State/Province
Alabama
Country
United States
City
Birmingham
State/Province
Alabama
Country
United States
City
Hueytown
State/Province
Alabama
Country
United States
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Huntsville
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Alabama
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Mobile
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Alabama
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United States
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Tallassee
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Alabama
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Tuscaloosa
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Alabama
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Phoenix
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Arizona
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Scottsdale
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Arizona
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Tucson
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Arizona
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Little Rock
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Arkansas
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North Little Rock
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Arkansas
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Anaheim
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California
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Azusa
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California
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Carmichael
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California
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Chula Vista
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California
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Cypress
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California
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Fresno
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California
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United States
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Fullerton
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California
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United States
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Garden Grove
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California
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Irvine
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California
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Lancaster
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California
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United States
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Long Beach
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California
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United States
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Los Angeles
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California
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United States
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Mission Hills
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California
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United States
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Modesto
State/Province
California
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United States
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Newport Beach
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California
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United States
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Oakland
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California
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Orange
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California
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United States
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Palm Springs
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California
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Pasadena
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California
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Redwood City
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California
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San Diego
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California
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San Luis Obispo
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California
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Santa Maria
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California
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Boulder
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Colorado
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Colorado Springs
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Colorado
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Denver
State/Province
Colorado
Country
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City
Littleton
State/Province
Colorado
Country
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City
Lone Tree
State/Province
Colorado
Country
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Longmont
State/Province
Colorado
Country
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Wheat Ridge
State/Province
Colorado
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Bristol
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Connecticut
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Waterbury
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Connecticut
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Newark
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Delaware
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Boynton Beach
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Florida
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Fort Myers
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Florida
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Jacksonville
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Florida
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Jupiter
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Florida
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Kissimmee
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Florida
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Lakeland
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Florida
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Miami
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Florida
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United States
City
Naples
State/Province
Florida
Country
United States
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New Port Richey
State/Province
Florida
Country
United States
City
New Smyrna Beach
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
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Pembroke Pines
State/Province
Florida
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Port Orange
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Florida
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United States
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Sarasota
State/Province
Florida
Country
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St. Petersburg
State/Province
Florida
Country
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Zephyrhills
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Florida
Country
United States
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Atlanta
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Georgia
Country
United States
City
Honolulu
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Hawaii
Country
United States
City
Arlington Heights
State/Province
Illinois
Country
United States
City
Champaign
State/Province
Illinois
Country
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City
Chicago
State/Province
Illinois
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United States
City
Hines
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Illinois
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City
Moline
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Illinois
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United States
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North Chicago
State/Province
Illinois
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United States
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Oak Forest
State/Province
Illinois
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United States
City
Oak Park
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Illinois
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United States
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Rockford
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Illinois
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Springfield
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Illinois
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City
Evansville
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Indiana
Country
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City
Indianapolis
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Indiana
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City
Newburgh
State/Province
Indiana
Country
United States
City
Clive
State/Province
Iowa
Country
United States
City
Davenport
State/Province
Iowa
Country
United States
City
Dubuque
State/Province
Iowa
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Newton
State/Province
Kansas
Country
United States
City
Shawnee Mission
State/Province
Kansas
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Chevy Chase
State/Province
Maryland
Country
United States
City
Hollywood
State/Province
Maryland
Country
United States
City
Lutherville
State/Province
Maryland
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City
Prince Frederick
State/Province
Maryland
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Chaska
State/Province
Minnesota
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
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Jefferson City
State/Province
Missouri
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Mexico
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Washington
State/Province
Missouri
Country
United States
City
Missoula
State/Province
Montana
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Pahrump
State/Province
Nevada
Country
United States
City
Egg Harbor Township
State/Province
New Jersey
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Binghamton
State/Province
New York
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Great Neck
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Elkin
State/Province
North Carolina
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Harrisburg
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Bismarck
State/Province
North Dakota
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Cincinatti
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Mayfield Heights
State/Province
Ohio
Country
United States
City
Mogadore
State/Province
Ohio
Country
United States
City
Warren
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Beaver Falls
State/Province
Pennsylvania
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Lansdale
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Hermitage
State/Province
Tennessee
Country
United States
City
Jackson
State/Province
Tennessee
Country
United States
City
Johnson City
State/Province
Tennessee
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Beaumont
State/Province
Texas
Country
United States
City
Bryan
State/Province
Texas
Country
United States
City
Conroe
State/Province
Texas
Country
United States
City
Corsicana
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Odessa
State/Province
Texas
Country
United States
City
Pharr
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Seguin
State/Province
Texas
Country
United States
City
Tyler
State/Province
Texas
Country
United States
City
Bountiful
State/Province
Utah
Country
United States
City
Ogden
State/Province
Utah
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
West Jordan
State/Province
Utah
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
City
Danville
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
City
Lakewood
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Monroe
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21129076
Citation
Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24.
Results Reference
result
PubMed Identifier
21118280
Citation
Dabholkar AH, Han C, Paris MM, Perez MC, Atkinson SN, Peura DA. The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Feb;33(3):366-77. doi: 10.1111/j.1365-2036.2010.04519.x. Epub 2010 Nov 30.
Results Reference
result
PubMed Identifier
19735233
Citation
Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.
Results Reference
result

Learn more about this trial

Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

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