Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

Overview

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

Full Title of Study: “A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory 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)
  • Study Primary Completion Date: May 2014

Detailed Description

A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis

Interventions

  • Drug: Esomeprazole (D961H) twice daily
    • One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
  • Drug: Esomeprazole (D961H) once daily
    • One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening

Arms, Groups and Cohorts

  • Experimental: D961H 20mg twice daily
    • Double-blinded
  • Active Comparator: D961H 20mg once daily
    • Double-blinded

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Healing of RE Who Were Graded “O” at Week 8 Out of Participants Who Were Graded “A” to “D” at Baseline According to Los Angeles Classification
    • Time Frame: 8 Weeks
    • Percentage of participants with healing of reflux esophagitis (RE) who were graded “O” (No RE) at Week 8 out of participants who were graded “A” (least severe) to “D” (most severe) at baseline according to Los Angeles classification

Secondary Measures

  • Percentage of Participants With Healing of RE Who Were Graded “O” at Week 4 Out of Participants Who Were Graded “A” to “D” at Baseline According to Los Angeles Classification
    • Time Frame: 4 Weeks
    • Percentage of participants with healing of reflux esophagitis (RE) who were graded “O” (No RE) at Week 4 out of participants who were graded “A” (least severe) to “D” (most severe) at baseline according to Los Angeles classification
  • Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
    • Time Frame: 4 Weeks
    • Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.
  • Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
    • Time Frame: 4 Weeks
    • Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.
  • Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
    • Time Frame: 4 Weeks
    • Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.
  • Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
    • Time Frame: 4 Weeks
    • Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.
  • Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4
    • Time Frame: 4 Weeks
    • Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.

Participating in This Clinical Trial

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures. 2. Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs. 3. Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1. 4. Patients who are able to complete the Patient Diary Exclusion Criteria:

1. Male or female aged less than 20 years at the time of informed consent. 2. Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc 3. Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation. 4. Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc 5. Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

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
    • Sponsor
  • Overall Official(s)
    • Tore Lind, MSD, Study Director, AstraZeneca, Moelndal, Sweden
    • Lan Chen, Study Director, AstraZeneca, Osaka, Japan
    • Yoshikazu Kinoshita, PROFESSOR OF MEDICINE, Principal Investigator, Dept of Gastroenterology and Hepatology, Shimane, Japan

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