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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Esomeprazole (NEXIUM) vs. surgery

Research Site

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.

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.

Age Continuous

Gender, Male/Female

Number of participants with treatment failure at 5 years

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 'Normal' at 5 year visit

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

Investigator-assessed heartburn severity at 5 year visit, participants with no heartburn

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

Total score for microscopic reflux-related changes in the distal esophagus 2 cm above the z-line, 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

Percentage time with pH<4 during 24-hour pH metry  at 5 year visit

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

Los Angeles (LA) grade 'B' at 5 year visit

Los Angeles (LA) grade C 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 mild heartburn

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 moderate heartburn

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

Investigator-assessed heartburn severity at 5 year visit, participants with severe heartburn

Overall Study

The study started with a 12-week run-in period. Patients had either been treated or untreated
with a proton pump inhibitor (PPI)  prior to entering this phase of the study.

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

Esomeprazole (NEXIUM) vs. surgery - LOTUS

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=434&filename=CSR-D9612C00003.pdf

CSR-D9612C00003.pdf

D9612C00003_CSP

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator