Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01562600
First received: March 22, 2012
Last updated: July 15, 2014
Last verified: July 2014

March 22, 2012
July 15, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
Number of Adverse Drug Reactions [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Adverse event incidence
Same as current
Complete list of historical versions of study NCT01562600 on ClinicalTrials.gov Archive Site
Non-recurrence rate of peptic ulcer [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation
Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With NSAIDs

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).

Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with NSAIDs

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

(Patients who have previous experience of Nexium given in the treatment for gastric ulcer or duodenal ulcer can be registered to this S-CEI.)

  • Gastric Ulcer
  • Duodenal Ulcer
Not Provided
Nexium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01562600
D961HC00012
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP