NCT01435525

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

2.5 years

First QC Date

September 14, 2011

Last Update Submit

April 14, 2014

Conditions

Gastric UlcerDuodenal UlcerGastric Mucosa-associated Lymphoid Tissue (MALT)Lymphoma Idiopathic Thrombocytopenic PurpuraEarly Gastric Cancer

Keywords

triple therapyHelicobacter pylorieradicationNexium

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Drug Reactions

    Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Secondary Outcomes (1)

  • Rate of H.Pylori eradication

    Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Study Arms (1)

Nexium

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients to whom triple therapy for H.pylori eradication to stomach is started after endoscopic treatment for gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, or early gastric cancer as the approved indication of Nexium. Patients with H.pylori negative at the time when the triple therapy is started are excluded.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Research Site

Aichi, Japan

Location

Research Site

Akita, Japan

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Research Site

Chiba, Japan

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Research Site

Ehime, Japan

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Research Site

Fukuoka, Japan

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Research Site

Fukushima, Japan

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Gifu, Japan

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Research Site

Gunma, Japan

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Research Site

Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Kagawa, Japan

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Kanagawa, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Mie, Japan

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Miyagi, Japan

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Research Site

Nagano, Japan

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Nagasaki, Japan

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Niigata, Japan

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Research Site

Numakunai, Japan

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Research Site

Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Ōita, Japan

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Saitama, Japan

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Shiga, Japan

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Shimane, Japan

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Shizuoka, Japan

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Research Site

Tokyo, Japan

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Toyama, Japan

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Research Site

Wakayama, Japan

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Research Site

Yamagata, Japan

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Research Site

Yamanashi, Japan

Location

MeSH Terms

Conditions

Stomach UlcerDuodenal UlcerStomach Neoplasms

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Shigeru Yoshida, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 16, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

JP(36)