Trial record 2 of 16 for:
Open Studies | "Stomach Ulcer"
Nexium Capsules LDA Specific Clinical Experience Investigation
Verified September 2014 by AstraZeneca
Information provided by (Responsible Party):
First received: November 14, 2012
Last updated: September 2, 2014
Last verified: September 2014
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).
||Observational Model: Cohort
Time Perspective: Prospective
||Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With LDA
Primary Outcome Measures:
Secondary Outcome Measures:
- Non-recurrence rate of peptic ulcer [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2017 (Final data collection date for primary outcome measure)
Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The patients who are continuously given Low dose Aspirin (LDA) to suppress thrombus/embolism and who will be given Nexium for the first time to suppress recurrence of gastric ulcer and duodenal ulcer.
(Patients who have previous experience of Nexium given in the treatment for gastric ulcer or duodenal ulcer can be registered to this S-CEI.)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01729182
||Shigeru Yoshida, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 14, 2012
||September 2, 2014
||Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Keywords provided by AstraZeneca:
Low dose Aspirin(LDA)
Gastric ulcer or duodenal ulcer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Digestive System Diseases