Nexium vs. Surgery - Full Text View

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

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

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