Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
NCT ID: NCT01669811
Last Updated: 2015-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1398 participants
INTERVENTIONAL
2012-08-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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D961H 20mg twice daily
Double-blinded
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
D961H 20mg once daily
Double-blinded
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tore Lind, MSD
Role: STUDY_DIRECTOR
AstraZeneca, Moelndal, Sweden
Lan Chen
Role: STUDY_DIRECTOR
AstraZeneca, Osaka, Japan
Yoshikazu Kinoshita, PROFESSOR OF MEDICINE
Role: PRINCIPAL_INVESTIGATOR
Dept of Gastroenterology and Hepatology, Shimane, Japan
Locations
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Research Site
Abiko-shi, , Japan
Research Site
Adachi-ku, , Japan
Research Site
Annaka-shi, , Japan
Research Site
Asahikawa-shi, , Japan
Research Site
Asakura-shi, , Japan
Research Site
Beppu-shi, , Japan
Research Site
Bunkyō City, , Japan
Research Site
Chūōku, , Japan
Research Site
Fujiidera-shi, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukushima, , Japan
Research Site
Gifu, , Japan
Research Site
Hamamatsu, , Japan
Research Site
Hirakata-shi, , Japan
Research Site
Hitachi-shi, , Japan
Research Site
Ibara-shi, , Japan
Research Site
Ichiki-Kushikino-shi, , Japan
Research Site
Ishikari-shi, , Japan
Research Site
Iwata-shi, , Japan
Research Site
Izumo-shi, , Japan
Research Site
Kagoshima, , Japan
Research Site
Kamakura-shi, , Japan
Research Site
Kanazawa, , Japan
Research Site
Karatsu-shi, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Kirishima-shi, , Japan
Research Site
Kita-ku, , Japan
Research Site
Kobe, , Japan
Research Site
Kochi, , Japan
Research Site
Koga-shi, , Japan
Research Site
Koriyama-shi, , Japan
Research Site
Kumagaya-shi, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kyoto, , Japan
Research Site
Machida-shi, , Japan
Research Site
Matsumoto-shi, , Japan
Research Site
Meguro-ku, , Japan
Research Site
Moriguchi-shi, , Japan
Research Site
Nishinomiya-shi, , Japan
Research Site
Ogori-shi, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, , Japan
Research Site
Otawara-shi, , Japan
Research Site
Ōita, , Japan
Research Site
Ōta-ku, , Japan
Research Site
Saga, , Japan
Research Site
Saitama-shi, , Japan
Research Site
Sakaide-shi, , Japan
Research Site
Sakushu, , Japan
Research Site
Sapporo, , Japan
Research Site
Sendai, , Japan
Research Site
Shibuya-ku, , Japan
Research Site
Shinagawa-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Takasaki-shi, , Japan
Research Site
Takatsuki-shi, , Japan
Research Site
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
Countries
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Related Links
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Other Identifiers
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D961UC00002
Identifier Type: -
Identifier Source: org_study_id
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