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Completed

NCT Number: NCT00644735

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

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).

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Key information

Conditions

Erosive Esophagitis Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Esomeprazole

Drug

Other names: Nexium

Lansoprazole

Drug

Other names: Prevacid

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.

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

  2. The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.

    Time frame: patients will undergo an endoscopy at Months 3 and 6

  3. To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Mar 27, 2008
Registry last updated
Mar 26, 2009

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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