JRCT ID: jRCT1080221998
Registered date:09/01/2013
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Refractory Reflux Esophagitis |
Date of first enrollment | 09/01/2013 |
Target sample size | 3750 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) | investigational material(s) Generic name etc : Pariet INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : Oral |
Outcome(s)
Primary Outcome | -Health related QOL -Symptoms of GERD Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | -Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy) |
Exclude criteria | -Patients with a history of hypersensitivity to any ingredients of PARIET. -Patients on atazanavir sulfate. |
Related Information
Primary Sponsor | Eisai Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-132044 |
Contact
Public contact | |
Name | |
Address | https://wcs.eisai.co.jp/i_005/wcat/p0201 |
Telephone | |
Affiliation | Eisai Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |