Esomeprazole (NEXIUM) vs. Surgery (LOTUS)
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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 3 |
| 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. |
- Number of Participants With Treatment Failure at 5 Years [ Time Frame: During 5 years ] [ Designated as safety issue: No ]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.
- Los Angeles (LA) Grade 'Normal' at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
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
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn
- 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 ] [ Designated as safety issue: No ]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
- Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included
- Los Angeles (LA) Grade 'A' at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
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
- Los Angeles (LA) Grade 'B' at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
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
- Los Angeles (LA) Grade C at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
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
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn
| Enrollment: | 626 |
| Study Start Date: | October 2001 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Surgery
|
Procedure: Laparoscopic fundoplication (surgery)
Surgery
|
|
Experimental: 2
Esomeprazole (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 |
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
Show 59 Study Locations| 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):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00251927 History of Changes |
| Other Study ID Numbers: | D9612C00003, SH-NEG-0003 |
| Study First Received: | November 9, 2005 |
| Results First Received: | July 8, 2010 |
| Last Updated: | August 7, 2012 |
| 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 May 16, 2013