Reflux Esophagitis Phase III Study (Initial Treatment)

Overview

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Full Title of Study: “A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Interventions

  • Drug: Esomeprazole
    • 20mg once daily
  • Drug: Esomeprazole
    • 40 mg once daily
  • Drug: Omeprazole
    • 20mg once daily

Arms, Groups and Cohorts

  • Experimental: 1
    • Esomeprazole 20mg
  • Experimental: 2
    • Esomeprazole 40mg
  • Active Comparator: 3
    • Omeprazole 20mg

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded “O” at Week 8 Out of Patients Who Were Graded “A, B, C or D” at Baseline According to Los Angeles Classification”.
    • Time Frame: 8 weeks
    • Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

Secondary Measures

  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded “O” at Week 4 Out of Patients Who Were Graded “A, B, C or D” at Baseline According to Los Angeles Classification
    • Time Frame: 4 weeks
    • Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

Participating in This Clinical Trial

Inclusion Criteria

  • Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation Exclusion Criteria:

  • Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. – Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Tore Lind / Medical Science Director, AstraZeneca
  • Overall Official(s)
    • Maotsugu Oyama, MD, PhD, Study Director, AstraZeneca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.