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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esomeprazole 20 mg | Other | esomeprazole 20 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole 20 mg | Drug | esomeprazole 20 mg once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masataka Date | AZ K.K. | Study Director |
| Makiko Abe | AZ K.K | Study Chair |
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Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 10 mg were included in this study.
First participant enrolled on 25 August 2011. Last participant completed on 31 January 2012. Out of 108 enrolled participants, 107 participants (target was 100) received esomeprazole 20 mg. All of the participants were included in safety analysis set and 104 out of the 107 participants were included in the full analysis set for efficacy analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 20 mg | esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 20 mg | esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks |
| 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 | Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed. | Efficacy Population (104 participants) | Posted | Mean | Standard Deviation | Days with heartburn | Baseline and 8 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 | Esomeprazole 20 mg | esomeprazole 20 mg once daily for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Typhoid Fever | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Armbrust | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004942 | Esophagitis, Peptic |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Baseline and 4 weeks |
| Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened". | Baseline and 4 weeks. |
| Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened". | Baseline and 8 weeks |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Used other proton pump inhibitor |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed. | 101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used. | Posted | Mean | Standard Deviation | Days with heartburn | Baseline and 4 weeks |
|
|
|
| Secondary | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened". | 101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used. | Posted | Number | Participants | Baseline and 4 weeks. |
|
|
|
| Secondary | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened". | Efficacy Population (104 participants) | Posted | Number | Participants | Baseline and 8 weeks |
|
|
|
| 2 |
| 107 |
| 2 |
| 107 |
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
| D004066 | Digestive System Diseases |
| D004941 | Esophagitis |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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