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
1 other identifier
interventional
1,398
1 country
63
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2012
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
August 14, 2015
CompletedAugust 27, 2015
August 1, 2015
1.7 years
August 17, 2012
May 18, 2015
August 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
8 Weeks
Secondary Outcomes (6)
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
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
4 Weeks
- +1 more secondary outcomes
Study Arms (2)
D961H 20mg twice daily
EXPERIMENTALDouble-blinded
D961H 20mg once daily
ACTIVE COMPARATORDouble-blinded
Interventions
One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (63)
Research Site
Abiko-shi, Japan
Research Site
Adachi-ku, Japan
Research Site
Annaka-shi, Japan
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Asahikawa-shi, Japan
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Asakura-shi, Japan
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Beppu-shi, Japan
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Bunkyō City, Japan
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Chūōku, Japan
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Fujiidera-shi, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hamamatsu, Japan
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Hirakata-shi, Japan
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Hitachi-shi, Japan
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Ibara-shi, Japan
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Ichiki-Kushikino-shi, Japan
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Ishikari-shi, Japan
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Iwata-shi, Japan
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Izumo-shi, Japan
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Kagoshima, Japan
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Kamakura-shi, Japan
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Kanazawa, Japan
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Karatsu-shi, Japan
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Kawasaki-shi, Japan
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Kirishima-shi, Japan
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Kita-ku, Japan
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Kobe, Japan
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Kochi, Japan
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Koga-shi, Japan
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Koriyama-shi, Japan
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Kumagaya-shi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Machida-shi, Japan
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Matsumoto-shi, Japan
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Meguro-ku, Japan
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Moriguchi-shi, Japan
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Nishinomiya-shi, Japan
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Ogori-shi, Japan
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Okayama, Japan
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Osaka, Japan
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Otawara-shi, Japan
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Ōita, Japan
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Ōta-ku, Japan
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Saga, Japan
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Saitama-shi, Japan
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Sakaide-shi, Japan
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Sakushu, Japan
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Sapporo, Japan
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Sendai, Japan
Research Site
Shibuya-ku, Japan
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Shinagawa-ku, Japan
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Shinjuku-ku, Japan
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Takasaki-shi, Japan
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Takatsuki-shi, Japan
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Toshima-ku, Japan
Research Site
Toyama, Japan
Research Site
Uji-shi, Japan
Research Site
Wakayama, Japan
Research Site
Yanagawa-shi, Japan
Research Site
Yokohama, Japan
Research Site
Yufu-shi, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Masahiro Nii
- Organization
- Clinical Statistics & Programming Department, Clinical Science Division, R&D, AstraZeneca Japan
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2012
First Posted
August 21, 2012
Study Start
August 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
August 27, 2015
Results First Posted
August 14, 2015
Record last verified: 2015-08