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Completed

NCT Number: NCT00251927

Esomeprazole (NEXIUM) vs. Surgery

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

40 mg oral tablet administered daily

Other names: Nexium®

Laparoscopic fundoplication (surgery)

Procedure

Surgery

Primary outcomes

  1. Number of Participants With Treatment Failure at 5 Years

    Time frame: During 5 years

    Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.

Secondary outcomes

  1. Los Angeles (LA) Grade 'Normal' at 5 Year Visit

    Time frame: At 5 year visit

    Endoscopic findings classified according to the Los Angeles classification:

    Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference

  2. Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn

    Time frame: At 5 year visit

    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn

  3. Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit

    Time frame: At 5 year visit

    The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included

  4. Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit

    Time frame: At 5 year visit

    Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included

  5. Los Angeles (LA) Grade 'A' at 5 Year Visit

    Time frame: At 5 year visit

    Endoscopic findings classified according to the Los Angeles classification:

    Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference

  6. Los Angeles (LA) Grade 'B' at 5 Year Visit

    Time frame: At 5 year visit

    Endoscopic findings classified according to the Los Angeles classification:

    Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference

  7. Los Angeles (LA) Grade C at 5 Year Visit

    Time frame: At 5 year visit

    Endoscopic findings classified according to the Los Angeles classification:

    Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference

  8. Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn

    Time frame: At 5 year visit

    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn

  9. Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn

    Time frame: At 5 year visit

    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn

  10. Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn

    Time frame: At 5 year visit

    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: LOTUS

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2005
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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