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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01435525
Other study ID # D961HC00011
Secondary ID
Status Completed
Phase N/A
First received September 14, 2011
Last updated April 14, 2014
Start date September 2011
Est. completion date March 2014

Study information

Verified date April 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium + amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual post-marketing use.


Description:

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication


Recruitment information / eligibility

Status Completed
Enrollment 369
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion criteria:

- Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric ulcer

- Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for duodenal ulcer

- Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric MALT lymphoma

- Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for idiopathic thrombocytopenic purpura

- Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for early gastric cancer

Exclusion Criteria:

- H.pylori negative at the time when the triple therapy is started

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Tokyo
Japan Research Site Toyama
Japan Research Site Wakayama
Japan Research Site Yamagata
Japan Research Site Yamanashi

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Drug Reactions Period from the start of triple therapy to assessment of eradication, an expected average of 3 months Yes
Secondary Rate of H.Pylori eradication Period from the start of triple therapy to assessment of eradication, an expected average of 3 months No
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