Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RELAX |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 40 mg twice daily | Experimental |
| |
| Esomeprazole 40 mg once daily | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Esomeprazole 40 mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period). | Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available. | Baseline to 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Nexium Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20110554 | Derived | Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28. |
| Label | URL |
|---|---|
| CSR-D9618C00001.pdf | View source |
Not provided
Four randomized patients were excluded from the ITT analysis due to missing efficacy data (2 patients), no investigational product given (1 patient), and being unblinded by the investigator (1 patient). The patient who received no investigational product was excluded from the safety analysis and is not included in the Baseline Characteristics.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 40 mg Twice Daily | Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily |
| FG001 | Esomeprazole 40 mg Once Daily | Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Esomeprazole |
| Drug |
Esomeprazole 40 mg once daily |
|
| Placebo | Drug | Placebo twice daily |
|
| Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores. | Baseline to 6 months |
| Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months | This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period. | Baseline to 6 months |
| Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma | Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. | Baseline to 6 months |
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period. | Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis. | From randomization (Visit 3) to visit 7. |
| Number of Patients With Severe Asthma Exacerbations. | Up to 6 months |
| Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7 | The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life). | From randomization (Visit 3) to Visit 7 |
| Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7 | The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5. | Randomization (Visit 3) to Visit 7 |
| Number of Severe Adverse Events | Up to 6 months |
| Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night | Participants must have both baseline and follow up measure to be included in analysis | Baseline to 6 months |
| Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day | Participants must have both baseline and follow up measure to be included in analysis | Baseline to 6 months |
| Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night | Participants must have both baseline and follow up measure to be included in analysis | Baseline to 6 months |
| Scottsdale |
| Arizona |
| United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Fountain Valley | California | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Stockbridge | Georgia | United States |
| Research Site | Normal | Illinois | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Mandeville | Louisiana | United States |
| Research Site | Wheaton | Maryland | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Papillion | Nebraska | United States |
| Research Site | Asheville | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Sylvania | Ohio | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Upland | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Greenfield | Wisconsin | United States |
| Research Site | Ciudad de Buenos Aires | Argentina | Argentina |
| Research Site | Monte Grande | Buenos Aires | Argentina |
| Research Site | Quilmes | Buenos Aires | Argentina |
| Research Site | Córdoba | Córdoba Province | Argentina |
| Research Site | Córdoba | Córdoba, Argentina | Argentina |
| Research Site | Rosario | Santa Fe Province | Argentina |
| Research Site | Rosario | Santa Fe, Argentina | Argentina |
| Research Site | San Miguel de Tucumán | Tucumán, Argentina | Argentina |
| Research Site | Buenos Aires | Argentina |
| Research Site | Pleven | Bulgaria |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Bay Roberts | Newfoundland and Labrador | Canada |
| Research Site | Holyrood | Newfoundland and Labrador | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Woodstock | Ontario | Canada |
| Research Site | La Malbaie | Quebec | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Benesov U Prahy | Czechia |
| Research Site | Beroun | Czechia |
| Research Site | Cvikov | Czechia |
| Research Site | Kladno | Czechia |
| Research Site | Kolín | Czechia |
| Research Site | Liberec | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Rokycany | Czechia |
| Research Site | Tábor | Czechia |
| Research Site | Brest | France |
| Research Site | Férolles-Attilly | France |
| Research Site | Grasse | France |
| Research Site | Grenoble | France |
| Research Site | Marseille | France |
| Research Site | Montpellier | France |
| Research Site | Paris | France |
| Research Site | Saint-Laurent-du-Var | France |
| Research Site | Villejuif | France |
| Research Site | Bad Wörishofen | Germany |
| Research Site | Berlin | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Freising | Germany |
| Research Site | Gelnhausen | Germany |
| Research Site | Gelsenkirchen | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Landsberg | Germany |
| Research Site | Marburg | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Rodgau-dudenhofen | Germany |
| Research Site | Wolmirstedt | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Füzesabony | Hungary |
| Research Site | Gyöngyös | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Hódmezővásárhely | Hungary |
| Research Site | Kaposvár | Hungary |
| Research Site | Mosonmagyaróvár | Hungary |
| Research Site | Százhalombatta | Hungary |
| Research Site | Szombathely | Hungary |
| Research Site | Cagliari | CA | Italy |
| Research Site | Crema | CR | Italy |
| Research Site | Florence | FI | Italy |
| Research Site | Arenzano | GE | Italy |
| Research Site | Palermo | PA | Italy |
| Research Site | Pisa | PI | Italy |
| Research Site | Prato | PO | Italy |
| Research Site | Roma | Roma | Italy |
| Research Site | Bussolengo | VR | Italy |
| Research Site | Verona | VR | Italy |
| Research Site | Naples | Italy |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Zapopan | Jalisco | Mexico |
| Research Site | Morelia | Michoacán | Mexico |
| Research Site | Villahermosa | Tabasco | Mexico |
| Research Site | México | Mexico |
| Research Site | Bydgoszcz | Poland |
| Research Site | Gdynia | Poland |
| Research Site | Iława | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Piekary Śląskie | Poland |
| Research Site | Skarżysko-Kamienna | Poland |
| Research Site | Strzelce Opolskie | Poland |
| Research Site | Tarnów | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Amadora | Portugal |
| Research Site | Covilha | Portugal |
| Research Site | Porto | Portugal |
| Research Site | Vila Nova de Gaia | Portugal |
| Research Site | Bratislava | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Nové Zámky | Slovakia |
| Research Site | Považská Bystrica | Slovakia |
| Research Site | Prievidza | Slovakia |
| Research Site | Rimavská Sobota | Slovakia |
| Research Site | Trenčín | Slovakia |
| Research Site | Basel | Canton of Basel-City | Switzerland |
| FG002 | Placebo | Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 40 mg Twice Daily | Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily |
| BG001 | Esomeprazole 40 mg Once Daily | Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily |
| BG002 | Placebo | Placebo |
| BG003 | 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, Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period). | Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period. | Posted | Least Squares Mean | Standard Error | L/minute | Baseline to 6 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available. | Posted | Least Squares Mean | Standard Error | L/minute | Baseline to 6 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to 6 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months | This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period. | Posted | Least Squares Mean | Standard Error | Inhalations | Baseline to 6 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma | Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. | Posted | Least Squares Mean | Standard Error | Percent of nights | Baseline to 6 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period. | Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis. | Posted | Least Squares Mean | Standard Error | Liters | From randomization (Visit 3) to visit 7. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Severe Asthma Exacerbations. | Posted | Number | Participants | Up to 6 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7 | The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life). | Posted | Least Squares Mean | Standard Error | Scores on a scale | From randomization (Visit 3) to Visit 7 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7 | The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Randomization (Visit 3) to Visit 7 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Severe Adverse Events | Posted | Number | Events | Up to 6 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night | Participants must have both baseline and follow up measure to be included in analysis | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to 6 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day | Participants must have both baseline and follow up measure to be included in analysis | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to 6 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night | Participants must have both baseline and follow up measure to be included in analysis | Posted | Least Squares Mean | Standard Error | Inhalations | Baseline to 6 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esomeprazole 40 mg Twice Daily | Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily | 7 | 319 | 37 | 319 | ||
| EG001 | Esomeprazole 40 mg Once Daily | Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily | 5 | 313 | 44 | 313 | ||
| EG002 | Placebo | Placebo | 5 | 328 | 55 | 328 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chronic Sinusitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Migraine With Aura | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sinus Polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Small Intestine Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
Numbers of patients analyzed in each of the Outcome Measures varies due to the amount of qualifying data captured for the patients.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ClinicalTrialTransparency | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| 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 |
Not provided
Not provided
| Male |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
Placebo |
|
|
|
|
|
|