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:	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.

Resource links provided by NLM:

MedlinePlus related topics: GERD Surgery

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
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

No publications provided

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

Keywords provided by AstraZeneca:

Acid reflux disease
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on February 04, 2010