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Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435525
First Posted: September 16, 2011
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01435525     History of Changes
Other Study ID Numbers: D961HC00011
First Submitted: September 14, 2011
First Posted: September 16, 2011
Last Update Posted: April 16, 2014
Last Verified: April 2014

Keywords provided by AstraZeneca:
triple therapy
Helicobacter pylori
eradication
Nexium

Additional relevant MeSH terms:
Ulcer
Stomach Neoplasms
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Esomeprazole