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Nexium vs. Surgery (LOTUS)
This study is ongoing, but not recruiting participants.
Study NCT00251927   Information provided by AstraZeneca
First Received: November 9, 2005   Last Updated: January 11, 2008   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP