NCT01215058

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2010

Enrollment Period

6 months

First QC Date

September 28, 2010

Last Update Submit

October 21, 2010

Conditions

Gastrointestinal HemorrhageUlcer

Keywords

Compliance, FranceGastrointestinal bleeding ulcer or symptomatic ulcer with NSAID

Outcome Measures

Primary Outcomes (1)

  • Gastroprotective agent compliance

    At the end of 1 month

Secondary Outcomes (1)

  • Clinical characteristics of those ulcers with NSAID

    At the end of 1 month

Study Arms (1)

1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospital sample

You may qualify if:

  • Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal HemorrhageUlcerPatient Compliance

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jean-Francois Bretagne

    Service gastro-enterologie et hepatologieCHRU Pontchaillou35033 RENNES cedex France

    STUDY CHAIR

  • Gerard Thiefin

    Service Hepato-Gastroenterologie CHU Reims51092 REIMS cedex France

    STUDY CHAIR

  • Genevieve BONNELYE

    KantarHealth - France138, avenue Marx Dormoy92120 Montrouge cedex

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 5, 2010

Study Start

October 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 22, 2010

Record last verified: 2010-10