A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
NCT ID: NCT02153398
Last Updated: 2017-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
55 participants
INTERVENTIONAL
2014-06-30
2016-04-30
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
NONE
Study Groups
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Group 1: D961H sachet 10 mg
Age: ≥1 year Weight: \<20 kg
D961H sachet 10 mg
Group 2: D961H capsule 10mg
Age: ≥1 year to 11years Weight: ≥20 kg
D961H capsule 10mg
Group 3: D961H capsule 20 mg
Age: ≥1 year to 11years Weight: ≥20 kg
D961H capsule 20 mg
Group 4: D961H capsule 10 mg
Age: 12 to 14 years Weight: ≥20 kg
D961H capsule 10mg
Group 5: D961H capsule 20 mg
Age: 12 to 14 years Weight: ≥20 kg
D961H capsule 20 mg
Interventions
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D961H sachet 10 mg
D961H capsule 10mg
D961H capsule 20 mg
Eligibility Criteria
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Inclusion Criteria
* Patients aged ≥ 1 year to 14 years old
* Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.
Exclusion Criteria
* Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration.
* Significant clinical illness within 4 weeks prior to the registration
* Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
* Positive for pregnancy test by urinary or lactation for post-menarchal females.
* Previous total gastrectomy
1 Year
14 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Bunkyō City, , Japan
Research Site
Fukuoka, , Japan
Research Site
Hiroshima, , Japan
Research Site
Izumi-shi, , Japan
Research Site
Maebashi, , Japan
Research Site
Matsumoto-shi, , Japan
Research Site
Osaka, , Japan
Research Site
Saitama-shi, , Japan
Research Site
Sapporo, , Japan
Research Site
Setagaya-ku, , Japan
Research Site
Shimotsuke-shi, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Suzaka-shi, , Japan
Research Site
Ureshino-shi, , Japan
Research Site
Yokohama, , Japan
Countries
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Other Identifiers
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26-022
Identifier Type: OTHER
Identifier Source: secondary_id
D961TC00002
Identifier Type: -
Identifier Source: org_study_id
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