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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-9537 | Registry Identifier | WHO |
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The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole 30 mg QD | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole | Drug | 30 mg capsule, orally, once daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21224838 | Result | 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. |
| Label | URL |
|---|---|
| Dexilant Package Insert | View source |
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Subjects eligible for entry into the Treatment Period were randomized into one of two, once-daily (QD) treatment groups.
Subjects were enrolled at 33 investigative sites in the United States from 07 March 2008 to 20 March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo capsules, orally, once daily for up to 4 weeks. |
| FG001 | Dexlansoprazole 30 mg QD | Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 1 capsule, orally, once daily for 4 weeks |
|
| Last 7 days of treatment |
| 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. | Last 7 days of treatment |
| Anaheim |
| California |
| United States |
| Garden Grove | California | United States |
| Lancaster | California | United States |
| Oakland | California | United States |
| San Diego | California | United States |
| Sherwood | California | United States |
| Westlake Village | California | United States |
| Jupiter | Florida | United States |
| Miami | Florida | United States |
| New Smyrna Beach | Florida | United States |
| Ocala | Florida | United States |
| St. Petersburg | Florida | United States |
| Zephyrhills | Florida | United States |
| Moline | Illinois | United States |
| Clive | Iowa | United States |
| Wichita | Kansas | United States |
| Metairie | Louisiana | United States |
| Prince Frederick | Maryland | United States |
| Jefferson City | Missouri | United States |
| Egg Harbor Town | New Jersey | United States |
| Great Neck | New York | United States |
| Greensboro | North Carolina | United States |
| Harrisburg | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Mogadore | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Duncansville | Pennsylvania | United States |
| Bristol | Tennessee | United States |
| Chattanooga | Tennessee | United States |
| Johnson City | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Nashville | Tennessee | United States |
| El Paso | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Odessa | Texas | United States |
| San Antonio | Texas | United States |
| Ogden | Utah | United States |
| Norfolk | Virginia | United States |
| Spokane | Washington | United States |
| Monroe | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo capsules, orally, once daily for up to 4 weeks. |
| BG001 | Dexlansoprazole 30 mg QD | Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks. |
| BG002 | 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, Customized | Number | participants |
| |||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||
| Number of Days with Night Heartburn | Baseline diary data were summarized using the non-missing diary entries from Study Day -8 to -2, inclusive. | Number | participants |
| ||||||||||||||||||
| Number of Nights with Sleep Disturbances Related to Gastroesophageal Reflux Disease (GERD) Symptoms | Baseline diary data were summarized using the non-missing diary entries from Study Day -8 to -2, inclusive. | 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 | 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. | Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment. | Posted | Median | Inter-Quartile Range | Percentage of nights | 4 Weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status. | Posted | Number | Percentage of participants | Last 7 days of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status. | Posted | Number | Percentage of participants | Last 7 days of treatment |
|
|
Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose.
Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.
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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 | Placebo capsules, orally, once daily for up to 4 weeks. | 1 | 153 | 3 | 153 | ||
| EG001 | Dexlansoprazole 30 mg QD | Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks. | 0 | 152 | 7 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortions Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (12.2) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA (12.2) | 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 at all study sites. 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 Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| D020447 | Parasomnias |
| 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 |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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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 |
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| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|
| 4-5 days |
|
| 6-7 days |
|
| 4-5 Nights |
|
| 6-7 Nights |
|
| Participants |
|
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| Participants |
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