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| Descriptive Information Fields | |||||||||
| Brief Title † | Nexium vs. Surgery | ||||||||
| Official Title † | An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-Term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-Reflux Surgery in Adult Subjects With Gastroesophageal Reflux Disease - LOTUS. | ||||||||
| Brief Summary | The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Time to treatment failure defined as need for medical treatment other than esomeprazole for control of reflux disease symptom [ Time Frame: Enrollment to treatment failure assessed at each visit ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Efficacy endpoints including histopathological changes, scores of symptom variables, endoscopic assessments, assessment of 24h pH & Safety variables including lab tests, & all serious adverse events [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ] Quality of life including patient reported outcomes assessed by GSRS & QOLRAD [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ] |
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| Condition † | Gastroesophageal Reflux | ||||||||
| Intervention † | Drug: esomeprazole Procedure: Laparoscopic fundoplication (surgery) |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 557 | ||||||||
| Start Date † | October 2001 | ||||||||
| Completion Date | December 2013 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Sweden, United Kingdom | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00251927 | ||||||||
| Organization ID | D9612C00003 | ||||||||
| Secondary IDs †† | SH-NEG-0003 | ||||||||
| Study Sponsor † | AstraZeneca | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | January 2008 | ||||||||
| First Received Date † | November 9, 2005 | ||||||||
| Last Updated Date | January 11, 2008 | ||||||||
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