Gastroesophageal RefluxNCT00681837
Prevalence of Gastroesophageal Reflux During Childhood and Teenage Years in France
An observational study of Gastroesophageal Reflux, run by AstraZeneca at 25 sites in China.
Trial summary
The purpose of this study is to assess prevalence of gastrooesophageal reflux during childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal reflux management Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 2,500 participants
- Where
- 25 sitesChina
- Study dates
- May 2008to Sep 2008
- 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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children recruited by both GPs and paediatricians
Who may be able to join
- children from 0 to 17years old seen in consultation
Who cannot join
None listed.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Fuzhou, Fujian
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Hefei, Anhui
Research Site
Jinan, Shandong
Research Site
Kunming, Yunnan
Research Site
Nanchang, Jiangxi
Research Site
Nanjing, Jiangsu
Research Site
Ningbo, Zhejiang
Research Site
Qingdao, Shandong
Research Site
Rui’an, Zhejiang
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenzhen, Guangdong
Research Site
Suzhou, Jiangsu
Research Site
Taiyuan, Shanxi
Research Site
Wenzhou, Zhejiang
Research Site
Wuhan, Hubei
Research Site
Wuxi, Jiangsu
Research Site
Xi’an, Shanxi
Research Site
Xiamen, Guangdong
Research Site
Zhengzhou, Henan
Research Site
Zhongshan, Guangdong
About this study
The purpose of this study is to assess prevalence of gastrooesophageal reflux during childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal reflux management
- Conditions
- Gastroesophageal Reflux
- Keywords
- gastroesophageal reflux, prevalence, childhood, France
- Medical subject headings
- Gastroesophageal Reflux
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 | children from 0 to 17 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess prevalence of gastrooesophageal reflux during childhood and teenage years in France, particularly 0-1 year-old prevalence and 1-11 year-old prevalence
Measured: At the end of the study
Secondary outcomes (1)
describe patients'symptoms and gastrooesophageal reflux management
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frédéric GOTTRAND, Study chair, CHRU Lille - FranceGeneviève BONNELYE, Principal investigator, TNS Healthcare 92120 Montrouge - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681837
- Sponsor's protocol ID
- NIS-GFR-DUM-2008/1
- Status last verified
- Nov 2008
- First submitted
- 19 May 2008
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gastroesophageal Reflux During Childhood and Teenage Years in France
- ClinicalTrials.gov ID
- NCT00681837
- Acronym / sponsor ID
- NIS-GFR-DUM-2008/1
- Conditions
- Gastroesophageal Reflux
- Keywords
- gastroesophageal reflux, prevalence, childhood, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Study completion
- Sep 2008 (actual)
- First posted
- 21 May 2008 (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 prevalence of gastrooesophageal reflux during childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal reflux management
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –children from 0 to 17 years old |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children recruited by both GPs and paediatricians
Key inclusion criteria (1 listed)
- children from 0 to 17years old seen in consultation
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
assess prevalence of gastrooesophageal reflux during childhood and teenage years in France, particularly 0-1 year-old prevalence and 1-11 year-old prevalence
Time frame: At the end of the study
1 secondary outcome
describe patients'symptoms and gastrooesophageal reflux management
Time frame: At the end of the study
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 18 Nov 2008.
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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.
Frédéric GOTTRAND study chair
CHRU Lille - France
Geneviève BONNELYE principal investigator
TNS Healthcare 92120 Montrouge - France
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by AstraZeneca at 25 sites in China.
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: finished, as of the sponsor's last update on 18 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. 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.
What does the primary outcome measure?
assess prevalence of gastrooesophageal reflux during childhood and teenage years in France, particularly 0-1 year-old prevalence and 1-11 year-old prevalence (time frame: At the end of the study). 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 18 Nov 2008; AzTrials last refreshed its copy on 8 Nov 2026.