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A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

Primary Purpose

Gastroesophageal Reflux

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

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Non-Erosive Gastroesophageal Reflux Disease, GERD, heartburn, sleep disturbance, nocturnal Reflux

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • History of nocturnal heartburn and GERD associated sleep disturbances prior to screening.
  • Meets both of the following criteria: 1) nocturnal heartburn severity of moderate, severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep disturbances on at least 3 of 7 nights.
  • Subjects must have history of symptomatic GERD prior to screening with GERD symptoms that were responsive to acid-suppressive therapy.

Exclusion Criteria:

  • Erosive esophagitis visualized during the screening endoscopy.
  • Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid.
  • Active gastric or duodenal ulcers within 30 days prior to randomization.
  • Upper gastrointestinal bleeding within 6 months prior to randomization.
  • Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus).
  • History of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
  • Subject requiring dilation for esophageal strictures and/or strictures preventing passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable.
  • Has another condition that could be the primary cause of the subject's sleep disturbance.
  • Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied) which may impact the ability of the subject to participate or potentially confound the trial results.
  • Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening.
  • Has a condition likely to require surgery during the study.
  • Currently diagnosed with acquired immunodeficiency syndrome (AIDS).
  • Abnormal clinical laboratory values.
  • History of alcoholism or drug addiction.
  • Subject who works the night shift.
  • Subject who is planning to travel beyond 3 time zones during the study.
  • Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to randomization or anticipated use during the study.
  • Use of the following medications during the 14 days prior to randomization or anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol, corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other than stable doses), psychotropic medications (other than stable doses), narcotic medications (occasional use allowed), bisphosphonates.
  • Use of sleep medications, first generation antihistamines, benzodiazepines, modified cyclic antidepressants, antianxiety medications or drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms (eg, selective-serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However, subjects who remain on a stable regimen and dose of these medications during the 90 days prior to randomization and who agree to maintain the same regimen and dose during the trial will qualify. Also, short term use of anticholinergics for trial related procedures is not exclusionary. Second generation antihistamines are not excluded.
  • Use of histamine (H2) receptor antagonists or antacids (except for trial supplied Gelusil) during the screening period or anticipated use during the treatment period.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexlansoprazole 30 mg QD

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.
Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.

Secondary Outcome Measures

Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.
Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.

Full Information

First Posted
February 21, 2008
Last Updated
April 25, 2011
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00627016
Brief Title
A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
Official Title
A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (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 determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
Detailed Description
This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Non-Erosive Gastroesophageal Reflux Disease, GERD, heartburn, sleep disturbance, nocturnal Reflux

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dexlansoprazole 30 mg QD
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole
Other Intervention Name(s)
TAK-390, T-168390, TAK-390MR, Kapidex, Dexilant
Intervention Description
30 mg capsule, orally, once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule, orally, once daily for 4 weeks
Primary Outcome Measure Information:
Title
Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.
Description
Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Description
Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.
Time Frame
Last 7 days of treatment
Title
Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Description
Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.
Time Frame
Last 7 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. History of nocturnal heartburn and GERD associated sleep disturbances prior to screening. Meets both of the following criteria: 1) nocturnal heartburn severity of moderate, severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep disturbances on at least 3 of 7 nights. Subjects must have history of symptomatic GERD prior to screening with GERD symptoms that were responsive to acid-suppressive therapy. Exclusion Criteria: Erosive esophagitis visualized during the screening endoscopy. Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid. Active gastric or duodenal ulcers within 30 days prior to randomization. Upper gastrointestinal bleeding within 6 months prior to randomization. Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus). History of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. Subject requiring dilation for esophageal strictures and/or strictures preventing passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable. Has another condition that could be the primary cause of the subject's sleep disturbance. Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied) which may impact the ability of the subject to participate or potentially confound the trial results. Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening. Has a condition likely to require surgery during the study. Currently diagnosed with acquired immunodeficiency syndrome (AIDS). Abnormal clinical laboratory values. History of alcoholism or drug addiction. Subject who works the night shift. Subject who is planning to travel beyond 3 time zones during the study. Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to randomization or anticipated use during the study. Use of the following medications during the 14 days prior to randomization or anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol, corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other than stable doses), psychotropic medications (other than stable doses), narcotic medications (occasional use allowed), bisphosphonates. Use of sleep medications, first generation antihistamines, benzodiazepines, modified cyclic antidepressants, antianxiety medications or drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms (eg, selective-serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However, subjects who remain on a stable regimen and dose of these medications during the 90 days prior to randomization and who agree to maintain the same regimen and dose during the trial will qualify. Also, short term use of anticholinergics for trial related procedures is not exclusionary. Second generation antihistamines are not excluded. Use of histamine (H2) receptor antagonists or antacids (except for trial supplied Gelusil) during the screening period or anticipated use during the treatment period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Chair
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Lancaster
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Sherwood
State/Province
California
Country
United States
City
Westlake Village
State/Province
California
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
New Smyrna Beach
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Saint Petersburg
State/Province
Florida
Country
United States
City
Zephyrhills
State/Province
Florida
Country
United States
City
Moline
State/Province
Illinois
Country
United States
City
Clive
State/Province
Iowa
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Prince Frederick
State/Province
Maryland
Country
United States
City
Jefferson City
State/Province
Missouri
Country
United States
City
Egg Harbor Town
State/Province
New Jersey
Country
United States
City
Great Neck
State/Province
New York
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Harrisburg
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Mogadore
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Chattanooga
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
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
San Antonio
State/Province
Texas
Country
United States
City
Ogden
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Monroe
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21224838
Citation
Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.
Results Reference
result

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A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

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