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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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | Treatment period is considered to be both weeks 1 and 2 between V3 and V4. | From randomisation to the 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 | Mobile | Alabama | 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 526 screened subjects, 341 subjects were randomised. From 341 subjects 170 and 171 were allocated to Esomeprazole and Placebo respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole | Esomeprazole magnesium trihydrate 22.3 mg |
| FG001 | Placebo | Placebo for Esomeprazole |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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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 of heartburn free days | 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 |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal 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 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 |
| San Francisco |
| California |
| United States |
| Research site | Westlake Village | California | United States |
| Research site | Lexington | Kentucky | United States |
| Research site | Rochester | New York | United States |
| Research site | Dakota Dunes | South Dakota | United States |
| Research site | Nashville | Tennessee | United States |
| Research site | Austin | Texas | United States |
| Research site | San Angelo | Texas | United States |
| Research site | West Jordan | Utah | 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 |
|
| Development of study specific withdrawal |
|
| Lost to follow up |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
| Secondary | Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | Treatment period is considered to be both weeks 1 and 2 between V3 and V4. | Full Analysis Set | Posted | Number | Participants | From randomisation to the 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 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. | Full Analysis Set | 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 of heartburn free days | From randomisation to day 14 |
|
|
|
| 0 |
| 162 |
| 18 |
| 162 |
| EG001 | Placebo | Placebo for Esomeprazole | 0 | 158 | 15 | 158 |
| Constipation | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Pain | General disorders |
|
| Pyrexia | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Procedural pain | Injury, poisoning and procedural complications |
|
| Blood glucose decreased | Investigations |
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| Blood glucose increased | Investigations |
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| Haemoglobin decreased | Investigations |
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| Hepatic enzyme increased | Investigations |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
| Headache | Nervous system 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 |
|
| First 7 calendar days |
|