Erosive EsophagitisPhase 4NCT00641602
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
A Phase 4 study testing Esomeprazole and Lansoprazole in people with Erosive Esophagitis, run by AstraZeneca.
Trial summary
This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Esomeprazole and Lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Aug 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.
- Confirmed Erosive Esophagitis within 1 week prior to starting the study.
Who cannot join
- Any signs of gastrointestinal bleeding at the time of the starting the study.
- Any previous gastric or esophageal surgery.
- Various gastrointestinal diseases as listed in the protocol.
About this study
Official title: A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.
This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole
- Conditions
- Erosive Esophagitis
- Being tested
- Esomeprazole, Lansoprazole
- Keywords
- Erosive Esophagitis, Nexium, Heartburn
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
40mg once daily
LansoprazoleDrug
Also called Prevacid
30mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nexium Receives: Drug: Esomeprazole |
| 2 | Active comparator | Prevacid Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.
Measured: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
Secondary outcomes (3)
1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.
Measured: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.
Measured: Dairy card to be completed by patient daily
To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.
Measured: Adverse event collection on an ongoing basis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startDec 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,000 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
- NCT00641602
- Sponsor's protocol ID
- 322
- Other IDs
- D9612L00046
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2008
- Last updated
- 26 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.
- ClinicalTrials.gov ID
- NCT00641602
- Acronym / sponsor ID
- 322
- Conditions
- Erosive Esophagitis
- Keywords
- Erosive Esophagitis, Nexium, Heartburn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 24 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 healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EsomeprazoleNexium |
| 2 | Active comparator | Drug: LansoprazolePrevacid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.
- Confirmed Erosive Esophagitis within 1 week prior to starting the study.
Key exclusion criteria (3 listed)
- Any signs of gastrointestinal bleeding at the time of the starting the study.
- Any previous gastric or esophageal surgery.
- Various gastrointestinal diseases as listed 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: Nexium40mg once daily | Drug | 1 |
| LansoprazoleAlso: Prevacid30mg once daily | Drug | 2 |
Primary outcome
To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.
Time frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
3 secondary outcomes
1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.
Time frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.
Time frame: Dairy card to be completed by patient daily
To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.
Time frame: Adverse event collection on an ongoing basis
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 26 Mar 2009.
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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 and Lansoprazole in people with Erosive Esophagitis, 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 2 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 26 Mar 2009. 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 difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale. (time frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)). 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 26 Mar 2009.