GERDNCT00524355

Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of GERD

An observational study of GERD, run by AstraZeneca at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To describe the frequency, type and severity of the symptoms in patients visiting the GI or internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: GERD
How many people: 2,717 participants
Where: 2 sitesVietnam
Study dates: Mar 2007to Nov 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: primary care clinics, private clinics and out-patient department at hospitals in cities and provinces of Viet Nam

Who may be able to join

Patients from both sexes, aged 18 years or older
Patients complaining of symptoms consistent with reflux disease

Who cannot join

Patients with GI cancer and those where the only reason for the visit is renewing the prescription are excluded

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

Research Site
Hanoi
Research Site
Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of the Gastroesophageal Reflux Disease

To describe the frequency, type and severity of the symptoms in patients visiting the GI or internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)

Conditions: GERD
Keywords: GERD, GIS, heartburn, NIS, PPI
Medical subject headings: Gastroesophageal Reflux, Heartburn

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Nov 2007

First posted3 Sep 2007 (estimated)
Study startMar 2007
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GERDStudies 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: 2,717 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00524355
Sponsor's protocol ID: NIS-GVN-NEX-2007/1
Other IDs: NIS-G84-GER-2007/2
Status last verified: Jul 2009
First submitted: 30 Aug 2007
Last updated: 17 Jul 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of the Gastroesophageal Reflux Disease
ClinicalTrials.gov ID: NCT00524355
Acronym / sponsor ID: NIS-GVN-NEX-2007/1
Conditions: GERD
Keywords: GERD, GIS, heartburn, NIS, PPI
Study type: Observational
Recruitment status: Completed
Enrolment: 2,717 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2007
Study completion: Nov 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.

To describe the frequency, type and severity of the symptoms in patients visiting the GI or internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)

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: primary care clinics, private clinics and out-patient department at hospitals in cities and provinces of Viet Nam

Key inclusion criteria (2 listed)

Patients from both sexes, aged 18 years or older
Patients complaining of symptoms consistent with reflux disease

Key exclusion criteria (1 listed)

Patients with GI cancer and those where the only reason for the visit is renewing the prescription are excluded

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 17 Jul 2009.

Related trials for GERD

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

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.

Ta Long, MD, PhD study chair

108 Hospital, Hanoi

Do Van Dung, MD, PhD study chair

Ho Chi Minh City Univ of Medicine and Pharmacist

Dao Van Long, MD, PhD principal investigator

Ha Noi University of Medicine Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of GERD, run by AstraZeneca at 2 sites in Vietnam.

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 2 inclusion and 1 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 17 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

On the ClinicalTrials.gov record for NCT00524355.

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 17 Jul 2009.