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 NSAIDs
| NCT number | NCT01562600 |
| Other study ID # | D961HC00012 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 19, 2012 |
| Est. completion date | August 27, 2015 |
| 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 non-steroidal anti-inflammatory drug (NSAID).
| Status | Completed |
| Enrollment | 1634 |
| Est. completion date | August 27, 2015 |
| Est. primary completion date | August 27, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: -Patients who are given NSAIDs for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given Nexium to suppress recurrence of gastric ulcer or duodenal ulcer. 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 | 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 | Adverse event incidence | 1 Year | |
| Secondary | Non-recurrence rate of peptic ulcer | 1 Year |
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|---|---|---|---|
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