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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No: 2006-002867-19 |
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To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 20 mg Once Daily (initial phase) | Experimental |
| |
| Esomeprazole 40 mg Once Daily (initial phase) | Experimental |
| |
| Esomeprazole 20 mg Once Daily (Maintenance Phase) | Experimental |
| |
| Esomeprazole 20 mg on Demand (Maintenance Phase) | Experimental |
| |
| Antacid Treatment (Maintenance Phase) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole (Nexium®) | Drug | This randomized study was conducted on parallel groups and included two phases:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Three Strategies of Long-term Treatment | Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment? | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). | Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator. The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca France Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Rouen | France |
The study included 2 phases (maximum treatment duration = 16 weeks):
Only maintenance phase data were reported in the Baseline module measures.
Patients were recruited by general practitioner between March 1, 2007 and July 21, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 20 mg Once Daily (Initial Phase) | |
| FG001 | Esomeprazole 40 mg Once Daily (Initial Phase) | |
| FG002 | Esomeprazole 20 mg Once Daily (Maintenance Phase) | |
| FG003 | Esomeprazole 20 mg on Demand (Maintenance Phase) | |
| FG004 | Antacid Treatment (Maintenance Phase) | antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Treatment Phase |
| |||||||||||||
| Maintenance Treatment Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 20 mg Once Daily (Maintenance Phase) | |
| BG001 | Esomeprazole 20 mg on Demand (Maintenance Phase) | |
| BG002 | Antacid Treatment (Maintenance Phase) |
| 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 | Efficacy of Three Strategies of Long-term Treatment | Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment? | Posted | Number | Percentage of participants with failure | 16 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 Once Daily (Initial Phase) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE BALTHAZAR E PANCREATITIS | Gastrointestinal disorders | MedDRA 10.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Vascular disorders | MedDRA 10.0 |
Planned number of patients not reached: statistical analysis plan revised,comparisons between treatment arms performed globally (No stratified analysis).
Safety pop=3032-3 incorrect enrolments (withdrawals at V2) with no information on ttmt received
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| 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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|
| Xolaam® | Drug | This randomized study was conducted on parallel groups and included two phases:
|
|
| 4 weeks |
| Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase | No possibility to describe as only 2 patients took ASA | 4 weeks |
| Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never) | 4 to 16 weeks |
| Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment | Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression) | 16 weeks |
| Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study | Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP. | 12 weeks - maintenance treatment phase |
| Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | May be used to evaluate the severity of symptoms during the initial visit. Not done | Day 0 |
| Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | May be used to offer patients a strategy of treatment during the initial phase and in the long term. Not done | Day 0 |
| Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) | May be used to define the success of treatment. Not done | Week 4 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day) |
|
|
| Secondary | Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). | Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator. The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item. | Posted | Number | Percentage of participants | 4 weeks |
|
|
|
| Secondary | Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase | No possibility to describe as only 2 patients took ASA | Outcome measure not possible to describe as only 2 patients took Aspirin. | Posted | 4 weeks |
|
|
| Secondary | Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never) | 871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data) | Posted | Mean | Standard Deviation | Scores on scale | 4 to 16 weeks |
|
|
|
| Secondary | Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment | Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression) | Posted | Number | Percent of participants with failure | 16 weeks |
|
|
|
| Secondary | Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study | Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP. | Posted | Number | Participants | 12 weeks - maintenance treatment phase |
|
|
|
| Secondary | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | May be used to evaluate the severity of symptoms during the initial visit. Not done | The results of exploratory analyses are not available. | Posted | Day 0 |
|
|
| Secondary | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | May be used to offer patients a strategy of treatment during the initial phase and in the long term. Not done | The results of exploratory analyses are not available. | Posted | Day 0 |
|
|
| Secondary | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) | May be used to define the success of treatment. Not done | The results of exploratory analyses are not available. | Posted | Week 4 |
|
|
| 8 |
| 2,156 |
| 32 |
| 2,156 |
| EG001 | Esomeprazole 40 mg Once Daily (Initial Phase) | 2 | 873 | 16 | 873 |
| EG002 | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 2 | 886 | 5 | 886 |
| EG003 | Esomeprazole 20 mg on Demand (Maintenance Phase) | 3 | 880 | 2 | 880 |
| EG004 | Antacid Treatment (Maintenance Phase) | antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day) | 4 | 851 | 13 | 851 |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 10.0 |
|
| ANXIO-DEPRESSI VE STATE | Psychiatric disorders | MedDRA 10.0 |
|
| AGGRAVATION OF INTERVERTEBRAL DISC HERNIATION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 10.0 |
|
| EROSIVE ANTRITIS | Gastrointestinal disorders | MedDRA 10.0 |
|
| BRONCHIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| SPONDYLOLISTHE SIS AGGRAVATION BY L5 SPONDYLOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
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| DEPRESSION | Psychiatric disorders | MedDRA 10.0 |
|
| PNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 |
|
| ADENOCARCINOM A OF GASTRIC ANTRUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| DIGESTIVE VIROSIS | Infections and infestations | MedDRA 10.0 |
|
| DEPRESSIVE DISEASE | Psychiatric disorders | MedDRA 10.0 |
|
| CARCINOMA OF OESOPHAGUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| PREEXISTING LUNG CARCINOMA AGGRAVATION | General disorders | MedDRA 10.0 |
|
| ADENOMATOUS POLYP | Gastrointestinal disorders | MedDRA 10.0 |
|
| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 10.0 |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) |
|
| Headache | Nervous system disorders | MedDRA (10.0) |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (10.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) |
|
| Chest pain | General disorders | MedDRA (10.0) |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (10.0) |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) |
|
| Asthenia | General disorders | MedDRA (10.0) |
|
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
|
| Somnolence | General disorders | MedDRA (10.0) |
|
| Weight decreased | Metabolism and nutrition disorders | MedDRA (10.0) |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (10.0) |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (10.0) |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.0) |
|
| Nervousness | Psychiatric disorders | MedDRA (10.0) |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (10.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
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| D004066 | Digestive System Diseases |
| 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 |