Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,Non-erosive Reflux Disease, Zollinger-Ellison Syndrome Clinical Trial
Official title:
Nexium Capsules Clinical Experience Investigation
The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed Nexium for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "Zollinger-Ellison syndrome"
| Status | Completed |
| Enrollment | 3691 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patients treated with Nexium for the first time due to gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome. Exclusion Criteria: - None |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Aichi | |
| Japan | Research Site | Akita | |
| Japan | Research Site | Aomori | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Ehime | |
| Japan | Research Site | Fukui | |
| 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 | Ishikawa | |
| Japan | Research Site | Iwate | |
| Japan | Research Site | Kagawa | |
| Japan | Research Site | Kagoshima | |
| 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 | Miyazaki | |
| Japan | Research Site | Nagano | |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Nara | |
| Japan | Research Site | Niigata | |
| Japan | Research Site | Oita | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Saga | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shimane | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Tochigi | |
| Japan | Research Site | Tokushima | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tottori | |
| Japan | Research Site | Toyama | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Yamagata | |
| Japan | Research Site | Yamaguchi | |
| Japan | Research Site | Yamanashi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Drug Reactions | Patients with gastric ulcer, anastomotic ulcer or Zollinger-Ellison syndrome: 8 weeks | Yes | |
| Primary | Number of Adverse Drug Reactions | Patients with duodenal ulcer: 6 weeks | Yes | |
| Primary | Number of Adverse Drug Reactions | Patients with reflux oesophagitis: 8 weeks | Yes | |
| Primary | Number of Adverse Drug Reactions | Patients with non-erosive reflux disease: 4 weeks | Yes |