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Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01435525
First received: September 14, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexium Capsules Specific Clinical Experience Investigation Concerning Helicobacter Pylori Eradication

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Adverse Drug Reactions [ Time Frame: Period from the start of triple therapy to assessment of eradication, an expected average of 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of H.Pylori eradication [ Time Frame: Period from the start of triple therapy to assessment of eradication, an expected average of 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: September 2011
Estimated Study Completion Date: June 2013

Detailed Description:

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435525

Contacts
Contact: AstraZeneca Japan Central Study Information M.Inoue@astrazeneca.com

Locations
Japan
Research Site Recruiting
Aichi, Japan
Research Unit Recruiting
Aichi, Japan
Research Unit Completed
Akita, Japan
Research Unit Completed
Chiba, Japan
Research Unit Completed
Ehime, Japan
Research Unit Recruiting
Fukuoka, Japan
Research Unit Completed
Fukushima, Japan
Research Unit Completed
Gifu, Japan
Research Unit Completed
Gunma, Japan
Research Unit Completed
Hiroshima, Japan
Research Unit Recruiting
Hokkaido, Japan
Research Unit Completed
Hyogo, Japan
Research Unit Completed
Ibaraki, Japan
Research Unit Completed
Iwate, Japan
Research Unit Completed
Kagawa, Japan
Research Unit Completed
Kanagawa, Japan
Research Unit Completed
Kochi, Japan
Research Unit Completed
Kumamoto, Japan
Research Unit Completed
Kyoto, Japan
Research Unit Completed
Mie, Japan
Research Unit Completed
Miyagi, Japan
Research Unit Completed
Nagano, Japan
Research Unit Completed
Nagasaki, Japan
Research Unit Completed
Niigata, Japan
Research Unit Recruiting
Oita, Japan
Research Site Completed
Okayama, Japan
Research Unit Completed
Okinawa, Japan
Research Unit Completed
Osaka, Japan
Research Unit Completed
Saitama, Japan
Research Unit Completed
Shiga, Japan
Research Unit Completed
Shimane, Japan
Research Unit Completed
Shizuoka, Japan
Research Unit Recruiting
Tokyo, Japan
Research Unit Completed
Toyama, Japan
Research Unit Recruiting
Wakayama, Japan
Research Unit Completed
Yamagata, Japan
Research Init Completed
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01435525     History of Changes
Other Study ID Numbers: D961HC00011
Study First Received: September 14, 2011
Last Updated: April 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
triple therapy
Helicobacter pylori
eradication
Nexium

Additional relevant MeSH terms:
Duodenal Diseases
Duodenal Ulcer
Lymphoma
Stomach Neoplasms
Purpura
Purpura, Thrombocytopenic
Stomach Ulcer
Ulcer
Purpura, Thrombocytopenic, Idiopathic
Lymphoma, B-Cell, Marginal Zone
Peptic Ulcer
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Stomach Diseases
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013