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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000419-90 | EudraCT Number | ||
| U1111-1113-9433 | Registry Identifier | WHO |
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The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.
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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 up to six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. | Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed. | 6 months |
| Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method | Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily 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 reported. | 6 months |
| Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19210298 | Result | Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7. | |
| 19735233 |
| Label | URL |
|---|---|
| For the Dexilant package insert refer to this link | View source |
Not provided
Subjects had to have endoscopically proven healed erosive esophagitis (EE) after 4 to 8 weeks of treatment with lansoprazole 30 mg once-daily (QD), dexlansoprazole modified release (MR) 60 mg QD, or dexlansoprazole MR 90 mg QD in the EE healing studies, T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719).
Subjects were enrolled at a total of 94 sites: 75 sites in the United States and 19 sites in Australia, Canada, the Czech Republic, Estonia, India, Latvia, Lithuania, Poland, and the Slovak Republic (date of first dose: 19 May 2006; date of last procedure: 21 May 2007).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD | Placebo capsules, orally, once daily for up to 6 months. |
| FG001 | Dexlansoprazole MR 30 mg QD | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexlansoprazole MR | Drug | Dexlansoprazole MR 60 mg, orally, once daily for up to six months. |
|
|
| Placebo | Drug | Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months. |
|
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. |
| 6 months |
| Percentage of Days Without Nighttime Heartburn as Assessed by Daily 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. | 6 months |
| Percentage of Days Without Nighttime Heartburn as Assessed by Daily 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. | 6 months |
| Tuscon |
| Arizona |
| United States |
| Anaheim | California | United States |
| Azusa | California | United States |
| Carmichael | California | United States |
| Chula Vista | California | United States |
| Cypress | California | United States |
| Fresno | California | United States |
| Garden Grove | California | United States |
| Harrisburg | California | United States |
| Irvine | California | United States |
| Lancaster | California | United States |
| Mission Hills | California | United States |
| Oakland | California | United States |
| Orange | California | United States |
| Pasadena | California | United States |
| San Diego | California | United States |
| San Luis Obispo | California | United States |
| Boulder | Colorado | United States |
| Colorado Springs | Colorado | United States |
| Wheat Ridge | Colorado | United States |
| Boynton Beach | Florida | United States |
| Jupiter | Florida | United States |
| Miami | Florida | United States |
| New Smyma Beach | Florida | United States |
| Ocala | Florida | United States |
| St. Petersburg | Florida | United States |
| Zephyrhills | Florida | United States |
| Atlanta | Georgia | United States |
| Honolulu | Hawaii | United States |
| Boise | Idaho | United States |
| Moline | Illinois | United States |
| Oak Forrest | Illinois | United States |
| Rockford | Illinois | United States |
| Clive | Iowa | United States |
| Lexington | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Metairie | Louisiana | United States |
| Chevy Chase | Maryland | United States |
| Hollywood | Maryland | United States |
| Lutherville | Maryland | United States |
| Prince Federick | Maryland | United States |
| Chaska | Minnesota | United States |
| Jackson | Mississippi | United States |
| Jefferson City | Missouri | United States |
| Washington | Missouri | United States |
| Egg Harbor | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Binghamton | New York | United States |
| Rochester | New York | United States |
| Greensboro | North Carolina | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Bismarck | North Dakota | United States |
| Dayton | Ohio | United States |
| Mogadore | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Medford | Oregon | United States |
| Portland | Oregon | United States |
| Duncansville | Pennsylvania | United States |
| Lansdale | Pennsylvania | United States |
| Anderson | South Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| Bristol | Tennessee | United States |
| Chattanooga | Tennessee | United States |
| Germantown | Tennessee | United States |
| Jackson | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Ogden | Utah | United States |
| Charlottesville | Virginia | United States |
| Chesapeake | Virginia | United States |
| Spokane | Washington | United States |
| Tacoma | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Monroe | Wisconsin | United States |
| Kippa-Ring | Australia |
| St. John's | Newfoundland and Labrador | Canada |
| Newmarket | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| Toronto | Ontario | Canada |
| Longueuil | Quebec | Canada |
| Regina | Saskatchewan | Canada |
| Hradec Králové | Czechia |
| Tallinn | Estonia |
| Riga | Latvia |
| Valmiera | Latvia |
| Kaunas | Lithuania |
| Panevezys | Lithuania |
| Vilnius | Lithuania |
| Bratislava | Slovakia |
| Nitra | Slovakia |
| Prešov | Slovakia |
| Sučany | Slovakia |
| 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. |
| 20195905 | Result | Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27. |
| 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. |
| FG002 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Placebo capsules, orally, once daily for up to 6 months. |
| BG001 | Dexlansoprazole MR 30 mg QD | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months. |
| BG002 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months. |
| 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 |
| ||||||||||||||||
| Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE) | Baseline values from Studies T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719), with severity of EE increasing from Grade A to Grade D. | Number | 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 Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. | Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed. | The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study. | Posted | Number | Percentage of Subjects | 6 months |
|
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| Secondary | Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily 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 reported. | The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment. | Posted | Median | Inter-Quartile Range | Percentage of Days | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily 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. | The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment. | Posted | Mean | Standard Deviation | Percentage of Days | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method | Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored. | Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored. | Posted | Number | Percentage of Subjects | 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Without Nighttime Heartburn as Assessed by Daily 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. | The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment. | Posted | Median | Inter-Quartile Range | Percentage of Days | 6 months |
|
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| Secondary | Percentage of Days Without Nighttime Heartburn as Assessed by Daily 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. | The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment. | Posted | Mean | Standard Deviation | Percentage of Days | 6 months |
|
|
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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 6 months. | 1 | 11 | ||||
| EG001 | Dexlansoprazole MR 30 mg QD | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months. | 2 | 26 | ||||
| EG002 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months. | 6 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant and Catheter Site Reactions | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain and Discomfort Not Elsewhere Classified (NEC) | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cholecystitis and Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bacterial Infections NEC | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Viral Infections NEC | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Limb Injuries NEC (Including [Incl] Traumatic Amputation) | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Non-Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Prostatic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
| |
| Cerebrovascular Venous and Sinus Thrombosis | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Migraine Headaches | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abortions Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 9.1 | Systematic Assessment |
| |
| Ovarian And Fallopian Tube Cysts and Neoplasms | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Uterine Disorders NEC | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bronchospasm and Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Peripheral Embolism and Thrombosis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea (Excluding [Excl] Infective) | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gastritis (Excl Infective) | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Musculoskeletal and Connective Tissue Signs and Symptoms NEC | Musculoskeletal and connective tissue 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 and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
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| 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 - <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 |
|
| B: ≥1 mucosal break ≥5 mm |
|
| C: ≥1 mucosal break <75% of circumference |
|
| D: ≥1 mucosal break ≥75% of circumference |
|
| <0.00001 |
Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo. |
| No |
| Superiority or Other |
| Fisher Exact | >0.99999 | Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
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| Units |
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| Counts |
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