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Efficacy and Safety 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
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 Non-Erosive Gastroesophageal Reflux Disease (GERD), Heartburn

Eligibility Criteria

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

Inclusion Criteria: Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn. History of episodes of heartburn for 6 months or longer prior to screening. History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary. Exclusion Criteria: Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study· Use of antacids (except for study supplied Gelusil®). Use of drugs with significant anticholinergic effects. Need for continuous anticoagulant (blood thinner) therapy. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter). Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy. Erosive Esophagitis seen on endoscopy during study screening. Co-existing diseases affecting the esophagus. Abnormal laboratory values that suggest significant clinical disease. Known acquired immunodeficiency syndrome (AIDS) Females pregnant or lactating. History of Alcohol abuse. History of Cancer within 3 years prior to screening. Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors 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 60 mg QD

Dexlansoprazole MR 90 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
November 8, 2005
Last Updated
April 25, 2011
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00251745
Brief Title
Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Official Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 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 daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with 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 daily Dexlansoprazole MR (60 mg and 90 mg) 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 non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. 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. Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (this posting, NCT00241745) and T-GD04-083 (NCT00251758), were combined and analyzed as a single larger study referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Non-Erosive 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
908 (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
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 60 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 90 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 with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn. History of episodes of heartburn for 6 months or longer prior to screening. History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary. Exclusion Criteria: Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study· Use of antacids (except for study supplied Gelusil®). Use of drugs with significant anticholinergic effects. Need for continuous anticoagulant (blood thinner) therapy. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter). Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy. Erosive Esophagitis seen on endoscopy during study screening. Co-existing diseases affecting the esophagus. Abnormal laboratory values that suggest significant clinical disease. Known acquired immunodeficiency syndrome (AIDS) Females pregnant or lactating. History of Alcohol abuse. History of Cancer within 3 years prior to screening. Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors 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:
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Alabaster
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Alabama
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United States
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Birmingham
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Huntsville
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Scottsdale
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Tucson
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Anaheim
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Chula Vista
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Fullerton
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Garden Grove
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Irvine
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Lancaster
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Long Beach
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Los Angeles
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Mission Hills
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Palm Springs
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Redwood City
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San Diego
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San Luis Obispo
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San Marino
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Boulder
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Colorado Springs
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Lone Tree
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Wheat Ridge
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Waterbury
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Jupiter
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Chicago
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Hines
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Rockford
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Clive
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Dubuque
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Newton
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Brooklyn
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Great Neck
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Rochester
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Charlotte
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Elkin
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Greensboro
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Hickory
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Salisbury
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Statesville
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Winston Salem
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Cincinnati
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Mayfield Heights
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Warren
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Oklahoma City
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Portland
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Beaver Falls
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Duncansville
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Lansdale
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Bristol
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Chattanooga
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Hermitage
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Nashville
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Austin
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Beaumont
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Bryan
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Corsicana
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El Paso
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Fort Worth
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Houston
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San Antonio
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Bountiful
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Ogden
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Salt Lake City
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West Jordan
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Chesapeake
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Danville
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Spokane
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Milwaukee
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Monroe
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United States

12. IPD Sharing Statement

Citations:
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

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Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn

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