Gastric Ulcer Clinical Trial
Official title:
Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With LDA
| NCT number | NCT01729182 |
| Other study ID # | D961PC00002 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2013 |
| Est. completion date | March 9, 2017 |
| Verified date | August 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).
| Status | Completed |
| Enrollment | 2363 |
| Est. completion date | March 9, 2017 |
| Est. primary completion date | March 9, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Exclusion Criteria: - Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy). - Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer. |
| 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 | Adverse events incidence | Number of Adverse Drug Reactions | Up to 2 years | |
| Secondary | Non-recurrence rate of peptic ulcer | Up to 2 years |
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