Back to resultsCompare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
Primary Purpose
Refractory Reflux Esophagitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Esomeprazole (D961H) twice daily
Esomeprazole (D961H) once daily
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Reflux Esophagitis focused on measuring Refractory Reflux Esophagitis,, Japanese,, Nexium,, twice daily,, oral administration
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- 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.
- 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.
- Patients who are able to complete the Patient Diary
Exclusion Criteria:
- Male or female aged less than 20 years at the time of informed consent.
- Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
- Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
- Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
- Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
D961H 20mg twice daily
D961H 20mg once daily
Arm Description
Double-blinded
Double-blinded
Outcomes
Primary Outcome 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
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 Outcome 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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01669811
Brief Title
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
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 Administration in Patients With Refractory Reflux Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Reflux Esophagitis
Keywords
Refractory Reflux Esophagitis,, Japanese,, Nexium,, twice daily,, oral administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D961H 20mg twice daily
Arm Type
Experimental
Arm Description
Double-blinded
Arm Title
D961H 20mg once daily
Arm Type
Active Comparator
Arm Description
Double-blinded
Intervention Type
Drug
Intervention Name(s)
Esomeprazole (D961H) twice daily
Intervention Description
One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
Intervention Type
Drug
Intervention Name(s)
Esomeprazole (D961H) once daily
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
4 Weeks
Title
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
Description
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.
Time Frame
4 Weeks
Title
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
Description
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.
Time Frame
4 Weeks
Title
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
Description
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.
Time Frame
4 Weeks
Title
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
Description
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.
Time Frame
4 Weeks
Title
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4
Description
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.
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures.
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.
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.
Patients who are able to complete the Patient Diary
Exclusion Criteria:
Male or female aged less than 20 years at the time of informed consent.
Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Lind, MSD
Organizational Affiliation
AstraZeneca, Moelndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lan Chen
Organizational Affiliation
AstraZeneca, Osaka, Japan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yoshikazu Kinoshita, PROFESSOR OF MEDICINE
Organizational Affiliation
Dept of Gastroenterology and Hepatology, Shimane, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Abiko-shi
Country
Japan
Facility Name
Research Site
City
Adachi-ku
Country
Japan
Facility Name
Research Site
City
Annaka-shi
Country
Japan
Facility Name
Research Site
City
Asahikawa-shi
Country
Japan
Facility Name
Research Site
City
Asakura-shi
Country
Japan
Facility Name
Research Site
City
Beppu-shi
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
Country
Japan
Facility Name
Research Site
City
Chuo-ku
Country
Japan
Facility Name
Research Site
City
Fujiidera-shi
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
Country
Japan
Facility Name
Research Site
City
Fukushima-shi
Country
Japan
Facility Name
Research Site
City
Gifu-shi
Country
Japan
Facility Name
Research Site
City
Hamamatsu-shi
Country
Japan
Facility Name
Research Site
City
Hirakata-shi
Country
Japan
Facility Name
Research Site
City
Hitachi-shi
Country
Japan
Facility Name
Research Site
City
Ibara-shi
Country
Japan
Facility Name
Research Site
City
Ichiki-Kushikino-shi
Country
Japan
Facility Name
Research Site
City
Ishikari-shi
Country
Japan
Facility Name
Research Site
City
Iwata-shi
Country
Japan
Facility Name
Research Site
City
Izumo-shi
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
Country
Japan
Facility Name
Research Site
City
Karatsu-shi
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
Country
Japan
Facility Name
Research Site
City
Kirishima-shi
Country
Japan
Facility Name
Research Site
City
Kita-ku
Country
Japan
Facility Name
Research Site
City
Kobe-shi
Country
Japan
Facility Name
Research Site
City
Kochi-shi
Country
Japan
Facility Name
Research Site
City
Koga-shi
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
Country
Japan
Facility Name
Research Site
City
Kumagaya-shi
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
Country
Japan
Facility Name
Research Site
City
Machida-shi
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
Country
Japan
Facility Name
Research Site
City
Meguro-ku
Country
Japan
Facility Name
Research Site
City
Moriguchi-shi
Country
Japan
Facility Name
Research Site
City
Nishinomiya-shi
Country
Japan
Facility Name
Research Site
City
Ogori-shi
Country
Japan
Facility Name
Research Site
City
Oita-shi
Country
Japan
Facility Name
Research Site
City
Okayama-shi
Country
Japan
Facility Name
Research Site
City
Osaka-shi
Country
Japan
Facility Name
Research Site
City
Ota-ku
Country
Japan
Facility Name
Research Site
City
Otawara-shi
Country
Japan
Facility Name
Research Site
City
Saga-shi
Country
Japan
Facility Name
Research Site
City
Saitama-shi
Country
Japan
Facility Name
Research Site
City
Sakaide-shi
Country
Japan
Facility Name
Research Site
City
Saku-shi
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
Country
Japan
Facility Name
Research Site
City
Sendai-shi
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
Country
Japan
Facility Name
Research Site
City
Takasaki-shi
Country
Japan
Facility Name
Research Site
City
Takatsuki-shi
Country
Japan
Facility Name
Research Site
City
Toshima-ku
Country
Japan
Facility Name
Research Site
City
Toyama-shi
Country
Japan
Facility Name
Research Site
City
Uji-shi
Country
Japan
Facility Name
Research Site
City
Wakayama-shi
Country
Japan
Facility Name
Research Site
City
Yanagawa-shi
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
Country
Japan
Facility Name
Research Site
City
Yufu-shi
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=712&filename=D961UC00002_Synopsis.pdf
Description
D961UC00002_Synopsis
Learn more about this trial
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
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