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Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01215058
First received: September 28, 2010
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  Purpose

The purpose of this study is to assess gastroprotective agent compliance in patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.


Condition
Gastrointestinal Hemorrhage
Ulcer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal Bleeding Ulcer or a Symptomatic Ulcer With Non-steroidal Anti-inflammatory Drug (NSAID) in France

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Gastroprotective agent compliance [ Time Frame: At the end of 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical characteristics of those ulcers with NSAID [ Time Frame: At the end of 1 month ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Hospital sample

Criteria

Inclusion Criteria:

  • Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215058

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Jean-Francois Bretagne Service gastro-enterologie et hepatologieCHRU Pontchaillou35033 RENNES cedex France
Study Chair: Gerard Thiefin Service Hepato-Gastroenterologie CHU Reims51092 REIMS cedex France
Principal Investigator: Genevieve BONNELYE KantarHealth - France138, avenue Marx Dormoy92120 Montrouge cedex
  More Information

No publications provided

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01215058     History of Changes
Other Study ID Numbers: NIS-PFR-DUM-2010/2
Study First Received: September 28, 2010
Last Updated: October 21, 2010
Health Authority: France: French Data Protection Authority

Keywords provided by AstraZeneca:
Compliance, France
Gastrointestinal bleeding ulcer or symptomatic ulcer with NSAID

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Ulcer
Stress, Psychological
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Behavioral Symptoms
Anti-Inflammatory Agents
 Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013