Gastrointestinal HemorrhageNCT01215058
Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer
An observational study of Gastrointestinal Hemorrhage and Ulcer, run by AstraZeneca.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Hemorrhage, Ulcer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hospital sample
Who may be able to join
- Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy
Who cannot join
None listed.
About this study
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
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.
- Conditions
- Gastrointestinal Hemorrhage, Ulcer
- Keywords
- Compliance, France, Gastrointestinal bleeding ulcer or symptomatic ulcer with NSAID
- Medical subject headings
- Gastrointestinal Hemorrhage, Ulcer, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroprotective agent compliance
Measured: At the end of 1 month
Secondary outcomes (1)
Clinical characteristics of those ulcers with NSAID
Measured: At the end of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Francois Bretagne, Study chair, Service gastro-enterologie et hepatologieCHRU Pontchaillou35033 RENNES cedex FranceGerard Thiefin, Study chair, Service Hepato-Gastroenterologie CHU Reims51092 REIMS cedex FranceGenevieve BONNELYE, Principal investigator, KantarHealth - France138, avenue Marx Dormoy92120 Montrouge cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215058
- Sponsor's protocol ID
- NIS-PFR-DUM-2010/2
- Status last verified
- Oct 2010
- First submitted
- 28 Sep 2010
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01215058
- Acronym / sponsor ID
- NIS-PFR-DUM-2010/2
- Conditions
- Gastrointestinal Hemorrhage, Ulcer
- Keywords
- Compliance, France, Gastrointestinal bleeding ulcer or symptomatic ulcer with NSAID
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital sample
Key inclusion criteria (1 listed)
- Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastroprotective agent compliance
Time frame: At the end of 1 month
1 secondary outcome
Clinical characteristics of those ulcers with NSAID
Time frame: At the end of 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Francois Bretagne study chair
Service gastro-enterologie et hepatologieCHRU Pontchaillou35033 RENNES cedex France
Gerard Thiefin study chair
Service Hepato-Gastroenterologie CHU Reims51092 REIMS cedex France
Genevieve BONNELYE principal investigator
KantarHealth - France138, avenue Marx Dormoy92120 Montrouge cedex
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage and Ulcer, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroprotective agent compliance (time frame: At the end of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2010.