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This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 20 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | From randomisation to day 14 | |
| Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | From randomization to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4. | From randomisation to day 14 |
| Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tore Lind, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Sacramento | California | United States | |||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31297231 | Derived | Peura D, Le Moigne A, Wassel H, Pollack C. Analysis of the symptom response to esomeprazole 20 mg over days 1-4 of a 14-day course of treatment for frequent heartburn: results of two randomised controlled trials. BMJ Open Gastroenterol. 2019 Jun 21;6(1):e000278. doi: 10.1136/bmjgast-2019-000278. eCollection 2019. | |
| 29788903 | Derived |
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From total of 486 enrolled subjects, 340 subjects were randomised. From 340 subjects 171 and 169 were allocated to Esomeprazole and Placebo respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole | Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate |
| FG001 | Placebo | Placebo for Esomeprazole |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole | Esomeprazole magnesium trihydrate 22.3 mg |
| BG001 | Placebo | Placebo for Esomeprazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | Full analysis set | Posted | Mean | Standard Deviation | Percentage | From randomisation to day 14 |
|
|
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Full analysis set (FAS) population was analyzed.
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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 | Esomeprazole | Esomeprazole magnesium trihydrate 22.3 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | 1625 518062 | +44 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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The first 4 consecutive days subjects were on randomized treatment, between V3 and V4. |
| From randomisation to the day 14 |
| Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn. | From randomisation to day 14 |
| Seminole |
| Florida |
| United States |
| Research site | Meridian | Idaho | United States |
| Research site | Indianapolis | Indiana | United States |
| Research site | Metairie | Louisiana | United States |
| Research site | Omaha | Nebraska | United States |
| Research site | Raleigh | North Carolina | United States |
| Research site | Cleveland | Ohio | United States |
| Research site | Mt. Pleasant | South Carolina | United States |
| Research site | San Antonio | Texas | United States |
| Peura DA, Le Moigne A, Wassel H, Pollack C. Sustained efficacy following resolution of frequent heartburn with an over-the-counter regimen of esomeprazole 20 mg or placebo for 14 days: two randomized trials. BMC Gastroenterol. 2018 May 22;18(1):69. doi: 10.1186/s12876-018-0790-2. |
| 27331882 | Derived | Peura D, Le Moigne A, Pollack C, Nagy P, Lind T. A 14-day regimen of esomeprazole 20 mg/day for frequent heartburn: durability of effects, symptomatic rebound, and treatment satisfaction. Postgrad Med. 2016 Aug;128(6):577-83. doi: 10.1080/00325481.2016.1203236. Epub 2016 Jul 4. |
| 25141241 | Derived | Peura DA, Traxler B, Kocun C, Lind T. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials. Postgrad Med. 2014 Jul;126(4):33-41. doi: 10.3810/pgm.2014.07.2781. |
| Adverse Event |
|
| Protocol Violation |
|
| Lost to follow up |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Randomized population was analyzed using criteria of white/ black or african american/ asian/ american indian or alaska native /white. | Number | Participants |
|
| Race/Ethnicity, Customized | Randomized population was analyzed using criteria of hispanic or latino/ not hispanic or latino/ not reported. | Number | Participants |
|
|
|
| Secondary | Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4. | Full Analysis Set | Posted | Number | Participants | From randomisation to day 14 |
|
|
|
| Secondary | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | The first 4 consecutive days subjects were on randomized treatment, between V3 and V4. | Full Analysis Set | Posted | Number | Participants | From randomisation to the day 14 |
|
|
|
| Secondary | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn. | Posted | Number | Participants | From randomisation to day 14 |
|
|
|
| Primary | Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | Per-protocol analysis set | Posted | Mean | Standard Deviation | Percentage | From randomization to day 14 |
|
|
|
| 0 |
| 168 |
| 18 |
| 168 |
| EG001 | Placebo | Placebo for Esomeprazole | 0 | 163 | 15 | 163 |
| Nausea | Gastrointestinal disorders |
|
| Diarhhoea | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Excoriation | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Haematuria | Renal and urinary disorders |
|
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| 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 |
| Two days |
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| Three days |
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| Four days |
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| First 7 calendar days |
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