Nexium vs. Surgery - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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:	626
Study Start Date:	October 2001
Study Completion Date:	April 2009

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

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Långström G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77.

ClinicalTrials.gov Identifier:	NCT00251927 History of Changes
Other Study ID Numbers:	D9612C00003, SH-NEG-0003
Study First Received:	November 9, 2005
Last Updated:	January 7, 2010
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:

Acid reflux disease
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012