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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Administrat

Brief Summary: 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

Detailed Summary: 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
Sponsor: AstraZeneca

Current Primary Outcome: 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


Original Primary Outcome: The proportion of subjects with healed Reflux Esophagitis (healing rate of RE) [ Time Frame: 8 Weeks ]

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • The presence/absence of RE according to the Los Angeles (LA)Classification [ Time Frame: 4 Weeks ]

    LA classification uses a four grade system:

    GRADE A:

    One or more mucosal breaks no longer than 5 mm, none of which extends between the tops of the mucosal folds. GRADE B:

    One or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds.

    GRADE C:

    Mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75% of the oesophageal circumference.

    GRADE D:

    Mucosal breaks which involve at least 75% of the oesophageal circumference.

  • The presence/absence of the patient-reported gastroesophageal reflux disease (GERD) symptoms according to Patient Diary [ Time Frame: 8 weeks ]
  • Severity of the patient-reported gastroesophageal reflux disease (GERD) symptoms according to Patient Diary. [ Time Frame: 8 weeks ]


Information By: AstraZeneca

Dates:
Date Received: August 17, 2012
Date Started: August 2012
Date Completion:
Last Updated: August 19, 2015
Last Verified: August 2015