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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000420-13 | EudraCT Number | ||
| U1111-1114-1935 | Registry Identifier | WHO |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole MR 30 mg QD | Experimental |
| |
| Dexlansoprazole MR 60 mg QD | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole MR | Drug | Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabaster | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19392864 | Result | 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. | |
| 19735233 |
| Label | URL |
|---|---|
| For the Dexilant package insert refer to this link | View source |
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Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of gastroesophageal reflux disease (GERD) should not be altered throughout the study.
Subjects enrolled at 154 sites in the United States (US); date of first dose: 08 June 2006; date of last procedure: 11 December 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD | Placebo capsules, orally, once daily for up to 4 weeks. |
| FG001 | Dexlansoprazole MR 30 mg QD | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexlansoprazole MR | Drug | Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks. |
|
|
| Placebo | Drug | Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks. |
|
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. |
| 4 weeks |
| Birmingham |
| Alabama |
| United States |
| Hueytown | Alabama | United States |
| Huntsville | Alabama | United States |
| Northport | Alabama | United States |
| Tallassee | Alabama | United States |
| Chandler | Arizona | United States |
| North Little Rock | Arizona | United States |
| Sun City | Arizona | United States |
| Tempe | Arizona | United States |
| Tucson | Arizona | United States |
| Anaheim | California | United States |
| Azusa | California | United States |
| Carmichael | California | United States |
| Chula Vista | California | United States |
| Clearwater | California | United States |
| Cypress | California | United States |
| Fountain Valley | California | United States |
| Fullerton | California | United States |
| Garden Grove | California | United States |
| Irvine | California | United States |
| Lancaster | California | United States |
| Mission Hills | California | United States |
| Oakland | California | United States |
| Orange | California | United States |
| Palm Springs | California | United States |
| Pasadena | California | United States |
| Redwood City | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| San Luis Obispo | California | United States |
| Vista | California | United States |
| Westlake Village | California | United States |
| Boulder | Colorado | United States |
| Colorado Springs | Colorado | United States |
| Littleton | Colorado | United States |
| Lone Tree | Colorado | United States |
| Wheat Ridge | Colorado | United States |
| Bristol | Connecticut | United States |
| Waterbury | Connecticut | United States |
| Boynton Beach | Florida | United States |
| Clearwater | Florida | United States |
| Holly Hill | Florida | United States |
| Jupitor | Florida | United States |
| Kissimmee | Florida | United States |
| Miami | Florida | United States |
| Naples | Florida | United States |
| New Smyma Beach | Florida | United States |
| Ocala | Florida | United States |
| Pembroke Pines | Florida | United States |
| St. Petersburg | Florida | United States |
| West Palm Beach | Florida | United States |
| Zephyrhills | Florida | United States |
| Atlanta | Georgia | United States |
| Conyers | Georgia | United States |
| Dunwoody | Georgia | United States |
| Stockbridge | Georgia | United States |
| Honolulu | Hawaii | United States |
| Boise | Idaho | United States |
| Moline | Illinois | United States |
| Oak Forrest | Illinois | United States |
| Rockford | Illinois | United States |
| Indianapolis | Indiana | United States |
| Clive | Iowa | United States |
| Dubuque | Iowa | United States |
| Overland | Kansas | United States |
| Wichita | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Metairie | Louisiana | United States |
| Baltimore | Maryland | United States |
| Chevy Chase | Maryland | United States |
| Hollywood | Maryland | United States |
| Lutherville | Maryland | United States |
| Prince Frederick | Maryland | United States |
| Troy | Michigan | United States |
| Chaska | Minnesota | United States |
| Jackson | Mississippi | United States |
| Olive Branch | Mississippi | United States |
| Jefferson City | Missouri | United States |
| Mexico | Missouri | United States |
| Washington | Missouri | United States |
| Butte | Montana | United States |
| Las Vegas | Nevada | United States |
| Pahrump | Nevada | United States |
| Egg Harbor Town | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Binghamton | New York | United States |
| Great Neck | New York | United States |
| Rochester | New York | United States |
| Charlotte | North Carolina | United States |
| Greensboro | North Carolina | United States |
| Harrisburg | North Carolina | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Statesville | North Carolina | United States |
| Bismarck | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Dayton | Ohio | United States |
| Franklin | Ohio | United States |
| Kettering | Ohio | United States |
| Lyndhurst | Ohio | United States |
| Mogadore | Ohio | United States |
| Sylvania | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Medford | Oregon | United States |
| Portland | Oregon | United States |
| Duncansville | Pennsylvania | United States |
| Harleysville | Pennsylvania | United States |
| Lansdale | Pennsylvania | United States |
| Levittown | Pennsylvania | United States |
| Anderson | South Carolina | United States |
| Charleston | South Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| Varnville | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Bristol | Tennessee | United States |
| Chattanooga | Tennessee | United States |
| Germantown | Tennessee | United States |
| Hermitage | Tennessee | United States |
| Jackson | Tennessee | United States |
| Johnson City | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Austin | Texas | United States |
| Beaumont | Texas | United States |
| Bellaire | Texas | United States |
| Bryan | Texas | United States |
| Carollton | Texas | United States |
| Conroe | Texas | United States |
| Corsicana | Texas | United States |
| Dallas | Texas | United States |
| El Paso | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Lake Jackson | Texas | United States |
| San Antonio | Texas | United States |
| Midvale | Utah | United States |
| Ogden | Utah | United States |
| Salt Lake City | Utah | United States |
| Charlottesville | Virginia | United States |
| Chesapeake | Virginia | United States |
| Norfold | Virginia | United States |
| Richmond | Virginia | United States |
| Lakewood | Washington | United States |
| Spokane | Washington | United States |
| Tacoma | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Monroe | Wisconsin | United States |
| 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. |
| 21129076 | Result | 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. |
| 24118079 | Derived | 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. |
| 23451835 | Derived | 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. |
| FG002 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Placebo capsules, orally, once daily for up to 4 weeks. |
| BG001 | Dexlansoprazole MR 30 mg QD | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks. |
| BG002 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes. | Posted | Median | Inter-Quartile Range | percentage of days | 4 weeks |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes. | Posted | Mean | Standard Deviation | percentage of days | 4 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later. | Posted | Median | Inter-Quartile Range | percentage of days | 4 weeks |
|
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| Secondary | 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. | Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later. | Posted | Mean | Standard Deviation | percentage of days | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QD | Placebo capsules, orally, once daily for up to 4 weeks. | 1 | 34 | ||||
| EG001 | Dexlansoprazole MR 30 mg QD | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks. | 2 | 41 | ||||
| EG002 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. | 1 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disorders Not Elsewhere Classified (NEC) | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Ischaemic Coronary Artery Disorders | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Heart Failures NEC | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sepsis, Bacteraemia, Viraemia and Fungaemia NEC | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Gastrointestinal & Abdominal Pains (Excluding Oral and Throat) | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Non-site Specific Gastrointestinal Haemorrhages | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Central Nervous System Haemorrhage & Cerebrovascular Accidents | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea (Excluding Infective) | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headaches NEC | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP Clinical Sciences | Takeda Global Research & Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| 45 to <65 years |
|
| ≥65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
The comparison between the two treatment groups was made using Wilcoxon rank-sum test. |
| Wilcoxon (Mann-Whitney) |
| <0.00001 |
The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method. |
| No |
| Superiority or Other |
| The comparison between the two treatment groups was made using Wilcoxon rank-sum test. | Wilcoxon (Mann-Whitney) | 0.72941 | Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons. | No | Superiority or Other |
| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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| Participants |
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