Patients With Upper Gastro-intestinal SymptomsGERD Q NISNCT01635959
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt
An observational study of Patients With Upper Gastro-intestinal Symptoms, run by AstraZeneca at 21 sites in Egypt.
Trial summary
The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Upper Gastro-intestinal Symptoms
- How many people
- 3,170 participants
- Where
- 21 sitesEgypt
- Study dates
- Jul 2012to Jul 2014
- 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: Community patients
Who may be able to join
- 18 years and above
- Attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting.
Who cannot join
- Participating on a clinical trial during the last 3 months.
- Patients not able to read and/or understand the GERD-Q questionnaire.
- Patients already included in the study in other participating site.
- Patients taking PPIs or H2blockers in the l
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Egypt21 sites
Research Site
Al Mansurah
Research Site
Al Menia
Research Site
Alex
Research Site
Asuit
Research Site
Aswān
Research Site
Banhā
Research Site
Cairo
Research Site
Domiaat
Research Site
Hurghada
Research Site
Ismailia
Research Site
Kafr ash Shaykh
Research Site
Kalubia
Research Site
Luxor
Research Site
Mahala
Research Site
Menofia
Research Site
Port-Saeed
Research Site
Qina
Research Site
Sharkiah
Research Site
Sohag
Research Site
Suiz
Research Site
Tanta
About this study
The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt.
Read the detailed description
Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt
- Keywords
- upper gastro-intestinal symptoms, GERD
- 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 |
|---|---|---|
| Patients with Gastrointestinal Trackt Symptoms | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients scoring ≥ 8 in GERD-Q
Percentage of patients scoring ≥ 8 in GERD-Q will be considered as suffering from GERD.
The GERD-Q is a potentially useful tool for family practitioners and other health care professionals in diagnosing and managing GERD without initial specialist referral or endoscopy.
The Egyptian-validated version of the GERD-Q will be used for the study purposes.
Measured: baseline
Secondary outcomes (2)
Socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD)
Descriptive analysis of socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt.
Measured: baseline
Treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD)
Descriptive analysis of treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Upper Gastro-intestinal SymptomsStudies 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
- Cross-sectional
- Enrolment
- 3,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dina A Ahmed, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635959
- Sponsor's protocol ID
- NIS-GEG-XXX-2012/1
- Acronym
- GERD Q NIS
- Status last verified
- Oct 2014
- First submitted
- 3 Jul 2012
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt
- ClinicalTrials.gov ID
- NCT01635959
- Acronym / sponsor ID
- GERD Q NIS / NIS-GEG-XXX-2012/1
- Keywords
- upper gastro-intestinal symptoms, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,170 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jul 2012 (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 calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt.
Detailed description
Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Gastrointestinal Trackt Symptoms | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community patients
Key inclusion criteria (2 listed)
- 18 years and above
- Attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting.
Key exclusion criteria (4 listed)
- Participating on a clinical trial during the last 3 months.
- Patients not able to read and/or understand the GERD-Q questionnaire.
- Patients already included in the study in other participating site.
- Patients taking PPIs or H2blockers in the l
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
Percentage of patients scoring ≥ 8 in GERD-Q
Time frame: baseline
Percentage of patients scoring ≥ 8 in GERD-Q will be considered as suffering from GERD. The GERD-Q is a potentially useful tool for family practitioners and other health care professionals in diagnosing and managing GERD without initial specialist referral or endoscopy. The Egyptian-validated version of the GERD-Q will be used for the study purposes.
2 secondary outcomes
Socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD)
Time frame: baseline
Treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD)
Time frame: baseline
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 3 Oct 2014.
Related trials for Patients With Upper Gastro-intestinal Symptoms
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Outcomes of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain.
Upper Abdominal Cancer Pain, Pancreatic Cancer
Active, not recruiting
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
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.
Dina A Ahmed, MD study director
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Upper Gastro-intestinal Symptoms, run by AstraZeneca at 21 sites in Egypt.
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 4 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 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Egypt. 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?
Percentage of patients scoring ≥ 8 in GERD-Q (time frame: baseline). 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 3 Oct 2014.