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Completed

NCT Number: NCT00641602

A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole

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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 Erosive Esophagitis within 1 week prior to starting 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

40mg once daily

Other names: Nexium

Lansoprazole

Drug

30mg once daily

Other names: Prevacid

Primary outcomes

  1. To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.

    Time frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)

Secondary outcomes

  1. 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.

    Time frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)

  2. 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.

    Time frame: Dairy card to be completed by patient daily

  3. To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.

    Time frame: Adverse event collection on an ongoing basis

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 24, 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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