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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 29, 2008 | ||||
| Last Updated Date | February 8, 2008 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists [ Time Frame: proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE. ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00612027 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
evaluation of a diagnosis tool [ Time Frame: evaluation of the predictive value of a two items questionnaire on acid associated symptoms ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions | ||||
| Official Title ICMJE | Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions | ||||
| Brief Summary | Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Gastrointestinal Diseases | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 29586 | ||||
| Completion Date | |||||
| Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00612027 | ||||
| Responsible Party | Dr Kai Richter, AstraZeneca Germany | ||||
| Study ID Numbers ICMJE | 1312004011, German PMS trial no.9 | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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