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Nexium vs. Surgery (LOTUS)

This study is ongoing, but not recruiting participants.

Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00251927
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: esomeprazole
Procedure: Laparoscopic fundoplication (surgery)
Phase III

MedlinePlus related topics:   GERD   

ChemIDplus related topics:   Esomeprazole magnesium    Esomeprazole Sodium    Omeprazole    Omeprazole magnesium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment:   557
Study Start Date:   October 2001
Estimated Study Completion Date:   December 2013
Estimated Primary Completion Date:   October 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Surgery
Procedure: Laparoscopic fundoplication (surgery)
Surgery
2: Experimental
Nexium therapy
Drug: esomeprazole
40 mg oral tablet administered daily

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251927

Show 59 study locations  Show 59 Study Locations

Sponsors and Collaborators
AstraZeneca

Investigators
Study Director:     AstraZeneca Nexium Medical Sciences Director, MD     AstraZeneca    
Principal Investigator:     Lars Lundell, MD, PhD     Karolinska University Hospital    
  More Information

Study ID Numbers:   D9612C00003, SH-NEG-0003
First Received:   November 9, 2005
Last Updated:   January 11, 2008
ClinicalTrials.gov Identifier:   NCT00251927
Health Authority:   Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:
Acid reflux disease  
Gastroesophageal Reflux Disease  

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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