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

AstraZeneca1,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,000

Conditions

Erosive Esophagitis

Interventions

EsomeprazoleDRUG

40mg once daily

LansoprazoleDRUG

30mg once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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. 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)

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.