Barrett's EsophagusPhase 4NCT00637559
Barrett's Esophagus - 315 - 3 Way Cross-Over
A Phase 4 study testing Esomeprazole Magnesium in people with Barrett's Esophagus, run by AstraZeneca.
Trial summary
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Esomeprazole Magnesium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Apr 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
Who cannot join
- A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
- History of various gastrointestinal diseases - please see investigator for full list.
- Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
- Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
About this study
Official title: A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
- Conditions
- Barrett's Esophagus
- Being tested
- Esomeprazole Magnesium
- Keywords
- Nexium, Barrett's esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole MagnesiumDrug
Also called Nexium
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 40mg twice daily Receives: Drug: Esomeprazole Magnesium |
| 2 | Experimental | 40mg three times daily Receives: Drug: Esomeprazole Magnesium |
| 3 | Experimental | 20mg three times daily Receives: Drug: Esomeprazole Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
Measured: pH measured on Day 5
Secondary outcomes (1)
Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
Measured: pH measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2002
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies 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
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paula Fernstrom, Study director, Nexium Global Product Director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637559
- Sponsor's protocol ID
- 315
- Other IDs
- D9612L00056
- Status last verified
- Jan 2011
- First submitted
- 11 Mar 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
- A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
- ClinicalTrials.gov ID
- NCT00637559
- Acronym / sponsor ID
- 315
- Conditions
- Barrett's Esophagus
- Keywords
- Nexium, Barrett's esophagus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 18 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 the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Esomeprazole Magnesium40mg twice daily |
| 2 | Experimental | Drug: Esomeprazole Magnesium40mg three times daily |
| 3 | Experimental | Drug: Esomeprazole Magnesium20mg three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
Key exclusion criteria (4 listed)
- A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
- History of various gastrointestinal diseases - please see investigator for full list.
- Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
- Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
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 |
|---|---|---|
| Esomeprazole MagnesiumAlso: Nexium | Drug | 1, 2, 3 |
Primary outcome
To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
Time frame: pH measured on Day 5
1 secondary outcome
Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
Time frame: pH measured
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.
Paula Fernstrom study director
Nexium Global Product Director, AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole Magnesium in people with Barrett's Esophagus, 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 1 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 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?
To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily. (time frame: pH measured on Day 5). 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.