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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669811
First Posted: August 21, 2012
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
August 17, 2012
August 21, 2012
May 18, 2015
August 14, 2015
August 27, 2015
August 2012
May 2014   (Final data collection date for primary outcome measure)
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
The proportion of subjects with healed Reflux Esophagitis (healing rate of RE) [ Time Frame: 8 Weeks ]
Complete list of historical versions of study NCT01669811 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
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
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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Refractory Reflux Esophagitis
  • 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
  • Experimental: D961H 20mg twice daily
    Double-blinded
    Intervention: Drug: Esomeprazole (D961H) twice daily
  • Active Comparator: D961H 20mg once daily
    Double-blinded
    Intervention: Drug: Esomeprazole (D961H) once daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1398
May 2014
May 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01669811
D961UC00002
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tore Lind, MSD AstraZeneca, Moelndal, Sweden
Study Director: Lan Chen AstraZeneca, Osaka, Japan
Principal Investigator: Yoshikazu Kinoshita, PROFESSOR OF MEDICINE Dept of Gastroenterology and Hepatology, Shimane, Japan
AstraZeneca
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP