| November 9, 2005 |
| January 11, 2008 |
| October 2001 |
| October 2013 (final data collection date for 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 ] |
- defined as need for medical treatment other than esomeprazole for control of reflux disease symptoms)
- Time to treatment failure
|
| Complete list of historical versions of study NCT00251927 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- - Efficacy endpoints including histopathological changes, scores of symptom variables, endoscopic assessments, assessment of 24h pH & Safety variables including lab tests, & all serious adverse events.
- - Quality of life including patient reported outcomes assessed by GSRS & QOLRAD
|
| |
| Nexium vs. Surgery |
| 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. |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Gastroesophageal Reflux |
- Drug: esomeprazole
- Procedure: Laparoscopic fundoplication (surgery)
|
- Active Comparator: Surgery
- Experimental: Nexium therapy
|
| |
| |
| Active, not recruiting |
| 557 |
| December 2013 |
| October 2013 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
- History of chronic reflux esophagitis or symptomatic GERD
Exclusion Criteria:
- History of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study.
- Contraindication to the study drug.
- Pregnancy, lactating or of child-bearing potential.
|
| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Sweden, United Kingdom |
| |
| NCT00251927 |
|
| D9612C00003, SH-NEG-0003 |
| AstraZeneca |
|
| Study Director: |
AstraZeneca Nexium Medical Sciences Director, MD |
AstraZeneca |
|
| Principal Investigator: |
Lars Lundell, MD, PhD |
Karolinska University Hospital |
|
|
| AstraZeneca |
| January 2008 |
