Nexium Capsules Helicobacter Pylori Specific Clinical Exp... | NCT01435525

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Sep 14, 2011

First Submission Date that Met QC Criteria

Sep 15, 2011

First Posted Date

Sep 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2014

Last Update Posted Date

Apr 16, 2014Estimated

Description Module

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.

Detailed Description

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

369Actual

Label	Type	Description	Intervention Names
Nexium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Adverse Drug Reactions		Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of H.Pylori eradication		Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Shigeru Yoshida, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aichi			Japan
Research Site

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D013276	Stomach Ulcer
D004381	Duodenal Ulcer
D013274	Stomach Neoplasms

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms