Gastric Acid SuppressionNCT01130935
Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
An observational study of Gastric Acid Suppression and Proton Pump Inhibitors, run by AstraZeneca at 14 sites in Albania.
Trial summary
This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Acid Suppression, Proton Pump Inhibitors
- How many people
- 491 participants
- Where
- 14 sitesAlbania
- Study dates
- May 2010to Nov 2010
- 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: Male or female subjects, age > 18 years, having had upper GI symptoms requiring acid suppression treatment.
Who may be able to join
- Subject must have had upper GI symptoms requiring acid suppression treatment
- Treatment with Nexium is in accordance with indications and dosing approved in Albania.
- Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed.
Who cannot join
- Known hypersensitivity to Nexium or any other constituents of the formulation
- Concomitant administration of atazanavir and nelfinavir.
- Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Albania14 sites
Research Site
Berat
Research Site
Burrel
Research Site
Durrës
Research Site
Elbasan
Research Site
Fier
Research Site
Kavajë
Research Site
Korçë
Research Site
Krujë
Research Site
Lezhë
Research Site
Lushnje
Research Site
Peshkopi
Research Site
Shkoder
Research Site
Tirana
Research Site
Vlorë
About this study
Official title: A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.
- Conditions
- Gastric Acid Suppression, Proton Pump Inhibitors
- Keywords
- GERD, gastric and duodenal ulcers, NSAID therapy
- Medical subject headings
- Gastroesophageal Reflux, Duodenal Ulcer
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.
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
Measured: Day 0
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
Measured: Week 2-4
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
Measured: Weeks 8-12
Secondary outcomes (7)
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Measured: Day 0
Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.
Measured: Once: Day 0
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Measured: Day 0
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Measured: Weeks 2-4
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Measured: Weeks 8-12
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Measured: Weeks 2-4
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Measured: Weeks 8-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Acid SuppressionStudies 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
- Prospective
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karin Otter, MD, PhD, Study director, Medical Director BBCSenka Riza, Study chair, Medical and Regulatory ManagerSkerdi Prifti, Asc.Proff., Principal investigator, University Hospital Center "Mother Teresa"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130935
- Sponsor's protocol ID
- NIS-GAL-NEX-2010/1
- Status last verified
- Feb 2011
- First submitted
- 20 May 2010
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
- ClinicalTrials.gov ID
- NCT01130935
- Acronym / sponsor ID
- NIS-GAL-NEX-2010/1
- Conditions
- Gastric Acid Suppression, Proton Pump Inhibitors
- Keywords
- GERD, gastric and duodenal ulcers, NSAID therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 May 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.
This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female subjects, age > 18 years, having had upper GI symptoms requiring acid suppression treatment.
Key inclusion criteria (3 listed)
- Subject must have had upper GI symptoms requiring acid suppression treatment
- Treatment with Nexium is in accordance with indications and dosing approved in Albania.
- Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed.
Key exclusion criteria (3 listed)
- Known hypersensitivity to Nexium or any other constituents of the formulation
- Concomitant administration of atazanavir and nelfinavir.
- Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease
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
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
Time frame: Day 0
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
Time frame: Week 2-4
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
Time frame: Weeks 8-12
7 secondary outcomes
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Time frame: Day 0
Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.
Time frame: Once: Day 0
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Time frame: Day 0
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Time frame: Weeks 2-4
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Time frame: Weeks 8-12
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Time frame: Weeks 2-4
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Time frame: Weeks 8-12
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 24 Feb 2011.
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.
Karin Otter, MD, PhD study director
Medical Director BBC
Senka Riza study chair
Medical and Regulatory Manager
Skerdi Prifti, Asc.Proff. principal investigator
University Hospital Center "Mother Teresa"
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Acid Suppression and Proton Pump Inhibitors, run by AstraZeneca at 14 sites in Albania.
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 3 inclusion and 3 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 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Albania. 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?
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. (time frame: Day 0). The study lists 3 primary outcomes in all. 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 24 Feb 2011.