CompletedPhase 4

Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

750 participantsStarted 2002-12

Plain-language summary

A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline * Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study. Exclusion Criteria: * Any signs of gastrointestinal bleeding at the time of the starting the study. * Any previous gastric or esophageal surgery. * Various gastrointestinal diseases as listed in the protocol.

What they're measuring

To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).

Timeframe: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Trial details

NCT IDNCT00644735

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-01

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