Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

NCT ID: NCT01435525

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Ulcer Duodenal Ulcer Gastric Mucosa-associated Lymphoid Tissue (MALT) Lymphoma Idiopathic Thrombocytopenic Purpura Early Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nexium

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shigeru Yoshida, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Aichi, , Japan

Site Status

Research Site

Akita, , Japan

Site Status

Research Site

Chiba, , Japan

Site Status

Research Site

Ehime, , Japan

Site Status

Research Site

Fukuoka, , Japan

Site Status

Research Site

Fukushima, , Japan

Site Status

Research Site

Gifu, , Japan

Site Status

Research Site

Gunma, , Japan

Site Status

Research Site

Hiroshima, , Japan

Site Status

Research Site

Hokkaido, , Japan

Site Status

Research Site

Hyōgo, , Japan

Site Status

Research Site

Ibaraki, , Japan

Site Status

Research Site

Kagawa, , Japan

Site Status

Research Site

Kanagawa, , Japan

Site Status

Research Site

Kochi, , Japan

Site Status

Research Site

Kumamoto, , Japan

Site Status

Research Site

Kyoto, , Japan

Site Status

Research Site

Mie, , Japan

Site Status

Research Site

Miyagi, , Japan

Site Status

Research Site

Nagano, , Japan

Site Status

Research Site

Nagasaki, , Japan

Site Status

Research Site

Niigata, , Japan

Site Status

Research Site

Numakunai, , Japan

Site Status

Research Site

Okayama, , Japan

Site Status

Research Site

Okinawa, , Japan

Site Status

Research Site

Osaka, , Japan

Site Status

Research Site

Ōita, , Japan

Site Status

Research Site

Saitama, , Japan

Site Status

Research Site

Shiga, , Japan

Site Status

Research Site

Shimane, , Japan

Site Status

Research Site

Shizuoka, , Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Research Site

Toyama, , Japan

Site Status

Research Site

Wakayama, , Japan

Site Status

Research Site

Yamagata, , Japan

Site Status

Research Site

Yamanashi, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D961HC00011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.