Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01435525
First received: September 14, 2011
Last updated: April 14, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 369
Study Start Date: September 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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, 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 14, 2014
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 Ulcer
Lymphoma
Stomach Neoplasms
Purpura
Purpura, Thrombocytopenic
Stomach Ulcer
Ulcer
Purpura, Thrombocytopenic, Idiopathic
Peptic Ulcer
Duodenal Diseases
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
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on August 20, 2014