search
Back to results

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexlansoprazole MR
Dexlansoprazole MR
Placebo
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(GERD), Heartburn

Eligibility Criteria

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

Inclusion Criteria: Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn). Subject has a history of episodes of heartburn for 6 months or longer prior to Screening. Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1. Exclusion Criteria: Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures. Subjects with erosive esophagitis (EE) as shown by endoscopy. Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome. Subject has abnormal laboratory values. Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose. Subject known to have acquired immunodeficiency syndrome (AIDS). Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid. Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate. Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors. Use of antacids (except for study-supplied Gelusil® ). Use of drugs with significant anticholinergic effects. Subjects who cannot discontinue the use of misoprostol or prokinetics Need for continuous anticoagulant therapy. Females who are pregnant or lactating. History of gastrointestinal surgery except for simple oversew of ulcer. History of cancer within 3 years prior to screening. Subject has participated in a previous Dexlansoprazole study. Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dexlansoprazole MR 30 mg QD

Dexlansoprazole MR 60 mg QD

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.

Secondary Outcome Measures

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.

Full Information

First Posted
May 2, 2006
Last Updated
April 25, 2011
Sponsor
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT00321984
Brief Title
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Official Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).
Detailed Description
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

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(GERD), Heartburn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
947 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexlansoprazole MR 30 mg QD
Arm Type
Experimental
Arm Title
Dexlansoprazole MR 60 mg QD
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole MR
Other Intervention Name(s)
TAK-390MR, Kapidex, Dexilant
Intervention Description
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
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 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
Primary Outcome Measure Information:
Title
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Description
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time Frame
4 weeks
Title
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Description
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Description
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time Frame
4 weeks
Title
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Description
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn). Subject has a history of episodes of heartburn for 6 months or longer prior to Screening. Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1. Exclusion Criteria: Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures. Subjects with erosive esophagitis (EE) as shown by endoscopy. Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome. Subject has abnormal laboratory values. Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose. Subject known to have acquired immunodeficiency syndrome (AIDS). Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid. Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate. Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors. Use of antacids (except for study-supplied Gelusil® ). Use of drugs with significant anticholinergic effects. Subjects who cannot discontinue the use of misoprostol or prokinetics Need for continuous anticoagulant therapy. Females who are pregnant or lactating. History of gastrointestinal surgery except for simple oversew of ulcer. History of cancer within 3 years prior to screening. Subject has participated in a previous Dexlansoprazole study. Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
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
Birmingham
State/Province
Alabama
Country
United States
City
Hueytown
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Northport
State/Province
Alabama
Country
United States
City
Tallassee
State/Province
Alabama
Country
United States
City
Chandler
State/Province
Arizona
Country
United States
City
North Little Rock
State/Province
Arizona
Country
United States
City
Sun City
State/Province
Arizona
Country
United States
City
Tempe
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Azusa
State/Province
California
Country
United States
City
Carmichael
State/Province
California
Country
United States
City
Chula Vista
State/Province
California
Country
United States
City
Clearwater
State/Province
California
Country
United States
City
Cypress
State/Province
California
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
Fullerton
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Irvine
State/Province
California
Country
United States
City
Lancaster
State/Province
California
Country
United States
City
Mission Hills
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Palm Springs
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
Redwood City
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
San Luis Obispo
State/Province
California
Country
United States
City
Vista
State/Province
California
Country
United States
City
Westlake Village
State/Province
California
Country
United States
City
Boulder
State/Province
Colorado
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Littleton
State/Province
Colorado
Country
United States
City
Lone Tree
State/Province
Colorado
Country
United States
City
Wheat Ridge
State/Province
Colorado
Country
United States
City
Bristol
State/Province
Connecticut
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Boynton Beach
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Holly Hill
State/Province
Florida
Country
United States
City
Jupitor
State/Province
Florida
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
New Smyma Beach
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Saint Petersburg
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Zephyrhills
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Conyers
State/Province
Georgia
Country
United States
City
Dunwoody
State/Province
Georgia
Country
United States
City
Stockbridge
State/Province
Georgia
Country
United States
City
Honolulu
State/Province
Hawaii
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Moline
State/Province
Illinois
Country
United States
City
Oak Forrest
State/Province
Illinois
Country
United States
City
Rockford
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Clive
State/Province
Iowa
Country
United States
City
Dubuque
State/Province
Iowa
Country
United States
City
Overland
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
Baltimore
State/Province
Maryland
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
Country
United States
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
City
Olive Branch
State/Province
Mississippi
Country
United States
City
Jefferson City
State/Province
Missouri
Country
United States
City
Mexico
State/Province
Missouri
Country
United States
City
Washington
State/Province
Missouri
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Pahrump
State/Province
Nevada
Country
United States
City
Egg Harbor Town
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
Great Neck
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
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
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Bismark
State/Province
North Dakota
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Franklin
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Mogadore
State/Province
Ohio
Country
United States
City
Sylvania
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
Duncansville
State/Province
Pennsylvania
Country
United States
City
Harleysville
State/Province
Pennsylvania
Country
United States
City
Lansdale
State/Province
Pennsylvania
Country
United States
City
Levittown
State/Province
Pennsylvania
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Varnville
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
Bellaire
State/Province
Texas
Country
United States
City
Bryan
State/Province
Texas
Country
United States
City
Carollton
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
Lake Jackson
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Midvale
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
Charlottesville
State/Province
Virginia
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
City
Norfold
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
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
19392864
Citation
Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.
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
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
24118079
Citation
Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1303-11. doi: 10.1111/apt.12504. Epub 2013 Sep 30.
Results Reference
derived
PubMed Identifier
23451835
Citation
Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. The effects of increasing body mass index on heartburn severity, frequency and response to treatment with dexlansoprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Apr;37(8):810-8. doi: 10.1111/apt.12270. Epub 2013 Mar 4.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

We'll reach out to this number within 24 hrs