Esomeprazole (NEXIUM) vs. Surgery (LOTUS)
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| ClinicalTrials.gov Identifier: NCT00251927 |
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Recruitment Status :
Completed
First Posted : November 11, 2005
Results First Posted : August 8, 2012
Last Update Posted : August 8, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroesophageal Reflux | Drug: esomeprazole Procedure: Laparoscopic fundoplication (surgery) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 626 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Study Start Date : | October 2001 |
| Actual Primary Completion Date : | April 2009 |
| Actual Study Completion Date : | April 2009 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Surgery
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Procedure: Laparoscopic fundoplication (surgery)
Surgery |
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Experimental: 2
Esomeprazole (NEXIUM) therapy
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Drug: esomeprazole
40 mg oral tablet administered daily
Other Name: Nexium® |
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251927
Show 59 study locations
| Study Director: | AstraZeneca Nexium Medical Sciences Director, MD | AstraZeneca | |
| Principal Investigator: | Lars Lundell, MD, PhD | Karolinska University Hospital |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00251927 |
| Other Study ID Numbers: |
D9612C00003 SH-NEG-0003 |
| First Posted: | November 11, 2005 Key Record Dates |
| Results First Posted: | August 8, 2012 |
| Last Update Posted: | August 8, 2012 |
| Last Verified: | August 2012 |
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Acid reflux disease Gastroesophageal Reflux Disease |
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Gastroesophageal Reflux Esophagitis, Peptic Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Esophagitis Gastroenteritis Peptic Ulcer |
Duodenal Diseases Intestinal Diseases Stomach Diseases Esomeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |