Reflux Esophagitis Phase III Study (Maintenance Treatment)

Overview

The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) 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 Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed 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
    • 10mg once daily oral administration
  • Drug: Esomeprazole
    • 20mg once daily oral administration
  • Drug: Omeprazole
    • 10mg once daily oral administration

Arms, Groups and Cohorts

  • Experimental: 1
    • Esomeprazole and Omeprazole
  • Experimental: 2
    • Esomeprazole

Clinical Trial Outcome Measures

Primary Measures

  • Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
    • Time Frame: Up to 24 weeks
    • Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.

Secondary Measures

  • Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
    • Time Frame: up to 4 weeks
    • Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
  • Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
    • Time Frame: Up to 12 weeks
    • Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002) – Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI 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

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