HeartburnSynchroniseNCT00524329
Esomeprazole And Symptomatic Response In Patients With Or Without An Elevated Risk For Non-Steroidal Anti-Inflammatory Drug (NSAID)-Associated GI Damage
An observational study of Heartburn, run by AstraZeneca.
Trial summary
The purpose of this study is to compare the treatment effect in patients with upper gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those without an elevated risk for NSAID-associated damage (as determined by the treating physician). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heartburn
- How many people
- 1,220 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Oct 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at general practitioner
Who may be able to join
- Patient with upper gastro-intestinal complaints (defined as heartburn and/or regurgitation and/or nausea and/or bloated feeling)and treatment with esomeprazole 20mg once daily is started because of this (consult 1). Upper gastro-intestinal complaints are thought to be related to NSAID use
- Patient is using an NSAID** with the following conditions:
- NSAID use has started at least one week before 1st consultation and is expected to be continued unchanged during the coming period (at least until consult 2)
- NSAID is taken at least 3 days a week
- ()OTC or Prescription NSAID
- ()Conventional NSAID or COX-2 selective NSAID
Who cannot join
- Use of a PPI and/or H2RA in the month preceding the study
- A history of reflux disease, not related to NSAID use
About this study
Official title: SYNCHRONISE: Esomeprazole 20 mg Once Daily for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs in Dutch General Practice: The Influence of Risk-Factors for NSAID-Associated GI Damage on Sympton Response
The purpose of this study is to compare the treatment effect in patients with upper gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those without an elevated risk for NSAID-associated damage (as determined by the treating physician).
- Conditions
- Heartburn
- Keywords
- upper GI-symptoms, heartburn, NSAID, risk, PPI, Bloating, Regurgitation
- Medical subject headings
- Heartburn, Gastroesophageal Reflux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies 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
- Time perspective
- Prospective
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrea Sellink, Study director, AstraZenecaN van den Berk, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524329
- Sponsor's protocol ID
- N13
- Acronym
- Synchronise
- Status last verified
- Sep 2008
- First submitted
- 29 Aug 2007
- Last updated
- 26 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNCHRONISE: Esomeprazole 20 mg Once Daily for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs in Dutch General Practice: The Influence of Risk-Factors for NSAID-Associated GI Damage on Sympton Response
- ClinicalTrials.gov ID
- NCT00524329
- Acronym / sponsor ID
- Synchronise / N13
- Conditions
- Heartburn
- Keywords
- upper GI-symptoms, heartburn, NSAID, risk, PPI, Bloating, Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Sep 2007 (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 compare the treatment effect in patients with upper gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those without an elevated risk for NSAID-associated damage (as determined by the treating physician).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at general practitioner
Key inclusion criteria (6 listed)
- Patient with upper gastro-intestinal complaints (defined as heartburn and/or regurgitation and/or nausea and/or bloated feeling)and treatment with esomeprazole 20mg once daily is started because of this (consult 1). Upper gastro-intestinal complaints are thought to be related to NSAID use
- Patient is using an NSAID** with the following conditions:
- ()OTC or Prescription NSAID
- ()Conventional NSAID or COX-2 selective NSAID
Key exclusion criteria (2 listed)
- Use of a PPI and/or H2RA in the month preceding the study
- A history of reflux disease, not related to NSAID use
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
Related trials for Heartburn
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
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.
Andrea Sellink study director
AstraZeneca
N van den Berk study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Heartburn, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 26 Sep 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 26 Sep 2008.