GERDPhase 4NCT00629564
An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
A Phase 4 study testing Esomeprazole in people with GERD, run by AstraZeneca.
Trial summary
This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GERD
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Oct 2002
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
- Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.]
- Able to communicate with the investigator and to understand and comply with the requirements of the study.
Who cannot join
- History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
- Abnormal lab test results, as indicated in the protocol.
- Other diseases, as indicated in the protocol.
About this study
This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)
- Conditions
- GERD
- Being tested
- Esomeprazole
- Keywords
- Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
20mg oral
EsomeprazoleDrug
Also called Nexium
15 minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 20mg oral Receives: Drug: Esomeprazole |
| 2 | Active comparator | 15 minute intravenous infusion Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
Measured: MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
Secondary outcomes (3)
Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)
Measured: BAO will be assessed after 10 days of treatment
To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.
Measured: Assessments at Day 2 and after Day 10 (Day 11 or Day 20)
To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.
Measured: Safety assessments throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startSep 2002
- Primary completionOct 2002
- Study completionOct 2002
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629564
- Sponsor's protocol ID
- SH-NEP-0012
- Other IDs
- D9615C00012
- Status last verified
- Jan 2011
- First submitted
- 27 Feb 2008
- Last updated
- 25 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00629564
- Acronym / sponsor ID
- SH-NEP-0012
- Conditions
- GERD
- Keywords
- Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 6 Mar 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.
This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Esomeprazole20mg oral |
| 2 | Active comparator | Drug: Esomeprazole15 minute intravenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
- Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.]
- Able to communicate with the investigator and to understand and comply with the requirements of the study.
Key exclusion criteria (5 listed)
- History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
- Abnormal lab test results, as indicated in the protocol.
- Other diseases, as indicated in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsomeprazoleAlso: Nexium20mg oral | Drug | 1 |
| EsomeprazoleAlso: Nexium15 minute intravenous infusion | Drug | 2 |
Primary outcome
The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
Time frame: MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
3 secondary outcomes
Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)
Time frame: BAO will be assessed after 10 days of treatment
To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.
Time frame: Assessments at Day 2 and after Day 10 (Day 11 or Day 20)
To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.
Time frame: Safety assessments throughout 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 25 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with GERD, 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 3 inclusion and 5 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 25 Jan 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods. (time frame: MAO will be assessed after 10 days of treatment (Day 11 or Day 20)). 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 25 Jan 2011.