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| ID | Type | Description | Link |
|---|---|---|---|
| NEON |
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The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nexium 40 mgs | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole 40 mg | Drug | Once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment | Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline | At Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment | Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline. | At Baseline and 4 weeks |
| Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Buenos Aires | Argentina | ||||
| Research Site |
All participants received 8-weeks open label esomeprazole treatment.
Participants with persisting symptoms of Gastroesophageal Reflux Disease (GORD) despite previous treatment with a full dose proton pump inhibitor were enrolled across the Argentina (6 sites), Chile (3 sites) Colombia (9 sites) and Venezuela (2 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 40mg, Daily | Open-label daily esomeprazole 40 mg, daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening |
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| Physical Exam | Procedure | every visit |
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| Quality of Life Questionnaires | Other | every visit |
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| pregnancy test, if applicable | Procedure | as needed |
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Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). |
| At Baseline and 8 weeks |
| Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment | Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 4 weeks |
| Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment. | Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 4 weeks. |
| Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment. | Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 8 weeks. |
| Change in Frequency of Epigastric Pain After 4 Weeks of Treatment | Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 4 weeks |
| Change in Frequency of Epigastric Pain After 8 Weeks of Treatment | Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe). | At Baseline and 8 weeks |
| Change in Severity of Epigastric Pain After 8 Weeks of Treatment | Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 8 weeks |
| Change in Severity of Epigastric Pain After 4 Weeks of Treatment | Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 4 weeks |
| Change in Severity of Acid Regurgitation After 8 Weeks of Treatment | Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 8 weeks |
| Change in Severity of Acid Regurgitation After 4 Weeks of Treatment | Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | At Baseline and 4 weeks |
| Santiago |
| Chile |
| Research Site | Temuco | Chile |
| Research Site | Viña del Mar | Chile |
| Research Site | Barranquilla | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Medellín | Colombia |
| Research Site | Barquisimeto | Venezuela |
| Research Site | Caracas | Venezuela |
| Research Site | San Cristóbal | Venezuela |
| COMPLETED |
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| NOT COMPLETED |
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| Open Label |
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 40mg, Daily | Open-label daily esomeprazole 40 mg, daily for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age at study entry | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Gender | Count of Participants | Participants |
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| 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 Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment | Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline | Posted | Sep 2009 | Mean | Standard Deviation | Days per week with symptoms | At Baseline and 8 weeks |
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| Secondary | Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment | Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline. | Posted | Sep 2009 | Mean | Standard Deviation | Days per week with symptoms | At Baseline and 4 weeks |
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| Secondary | Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment | Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Units of scale | At Baseline and 8 weeks |
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| Secondary | Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment | Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Units on scale | At Baseline and 4 weeks |
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| Secondary | Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment. | Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Days per week with symptoms | At Baseline and 4 weeks. |
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| Secondary | Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment. | Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Days per week with symptoms | At Baseline and 8 weeks. |
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| Secondary | Change in Frequency of Epigastric Pain After 4 Weeks of Treatment | Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Days per week with pain | At Baseline and 4 weeks |
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| Secondary | Change in Frequency of Epigastric Pain After 8 Weeks of Treatment | Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Days per week with pain | At Baseline and 8 weeks |
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| Secondary | Change in Severity of Epigastric Pain After 8 Weeks of Treatment | Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Units of scale | At Baseline and 8 weeks |
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| Secondary | Change in Severity of Epigastric Pain After 4 Weeks of Treatment | Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Units of scale | At Baseline and 4 weeks |
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| Secondary | Change in Severity of Acid Regurgitation After 8 Weeks of Treatment | Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Units of scale | At Baseline and 8 weeks |
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| Secondary | Change in Severity of Acid Regurgitation After 4 Weeks of Treatment | Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe). | Posted | Sep 2009 | Mean | Standard Deviation | Units of scale | At Baseline and 4 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 40mg, Daily | Open-label daily esomeprazole 40 mg, daily for 8 weeks | 4 | 317 | 16 | 317 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness / Hypotension / Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Uterine Leiomyoma | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| 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 |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D012149 | Restraint, Physical |
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| 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 |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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