Clinical trial NCT01435525: Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation
Official title: Nexium Capsules Specific Clinical Experience Investigation Concerning Helicobacter Pylori Eradication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Ulcer
Duodenal Ulcer
Gastric Mucosa-associated Lymphoid Tissue (MALT)
Lymphoma Idiopathic Thrombocytopenic Purpura
Early Gastric Cancer
Keywords: triple therapy
Helicobacter pylori
eradication
Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 369
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: Number of Adverse Drug Reactions
timeFrame: Period from the start of triple therapy to assessment of eradication, an expected average of 3 months
Secondary outcomes:
measure: Rate of H.Pylori eradication
timeFrame: Period from the start of triple therapy to assessment of eradication, an expected average of 3 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Shigeru Yoshida, MD
role: STUDY_DIRECTOR
References: