HeartburnPhase 4NCT00637845
Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)
A Phase 4 study testing Esomeprazole Magnesium and Lansoprazole in people with Heartburn and Gastroesophageal Reflux Disease, run by AstraZeneca.
Trial summary
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heartburn, Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole Magnesium and Lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Feb 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
- Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg twice daily during the 30 days prior to screening.
- Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of 14 days, where zero = none, one = mild, two = moderate, three = severe.
Who cannot join
- subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms, gastric or duodenal ulcers, or any other significant gastric or esophageal pathology judged to be clinically significant by the investigator.
- Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily for a period of > 6 months
- Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics of esomeprazole and/or lansoprazole.
About this study
Official title: A Multi-centred, Phase IV, Post-Marketing, Prospective, Randomized, Double-Blind Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease While on 30mg Once Daily Lansoprazole Therapy
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.
- Conditions
- Heartburn, Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole Magnesium, Lansoprazole
- Keywords
- Nexium, Esomeprazole Magnesium, Gastroesophageal Reflux Disease, Heartburn
- Medical subject headings
- Heartburn, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole MagnesiumDrug
Also called Nexium
40mg once daily
LansoprazoleDrug
Also called Prevacid
30mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 40mg once daily Receives: Drug: Esomeprazole Magnesium |
| 2 | Active comparator | 30mg twice daily Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the clinical efficacy of esomeprazole magnesium 40mg once daily versus lansoprazole 30 mg twice daily in symptom control of heartburn in subjects with heartburn symptoms resistant to 30 mg once daily therapy of lansoprazole.
Measured: Heartburn symptoms collected on diary card daily
Secondary outcomes (3)
To compare efficacy of esomeprazole magnesium 40mg daily vs lansoprazole 30 mg twice daily in symptom control of acid regurgitation, epigastric pain, and night-time heartburn in subjects with GERD symptoms resistant to 30 mg daily therapy of lansoprazole
Measured: Heartburn symptoms collected on diary card daily
To evaluate the use of supplementary antacids (as heartburn rescue therapy) in subjects treated with esomeprazole magnesium 40 mg once daily versus lansoprazole 30 mg twice daily
Measured: Heartburn symptoms collected on diary card daily
To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily.
Measured: Ongoing Adverse event collection
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 startJun 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
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
- NCT00637845
- Sponsor's protocol ID
- 311
- Other IDs
- D9612L00055
- Status last verified
- Jan 2011
- First submitted
- 11 Mar 2008
- Last updated
- 21 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centred, Phase IV, Post-Marketing, Prospective, Randomized, Double-Blind Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease While on 30mg Once Daily Lansoprazole Therapy
- ClinicalTrials.gov ID
- NCT00637845
- Acronym / sponsor ID
- 311
- Conditions
- Heartburn, Gastroesophageal Reflux Disease
- Keywords
- Nexium, Esomeprazole Magnesium, Gastroesophageal Reflux Disease, Heartburn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 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.
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Esomeprazole Magnesium40mg once daily |
| 2 | Active comparator | Drug: Lansoprazole30mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg twice daily during the 30 days prior to screening.
- Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of 14 days, where zero = none, one = mild, two = moderate, three = severe.
Key exclusion criteria (3 listed)
- subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms, gastric or duodenal ulcers, or any other significant gastric or esophageal pathology judged to be clinically significant by the investigator.
- Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily for a period of > 6 months
- Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics of esomeprazole and/or lansoprazole.
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: Nexium40mg once daily | Drug | 1 |
| LansoprazoleAlso: Prevacid30mg twice daily | Drug | 2 |
Primary outcome
To compare the clinical efficacy of esomeprazole magnesium 40mg once daily versus lansoprazole 30 mg twice daily in symptom control of heartburn in subjects with heartburn symptoms resistant to 30 mg once daily therapy of lansoprazole.
Time frame: Heartburn symptoms collected on diary card daily
3 secondary outcomes
To compare efficacy of esomeprazole magnesium 40mg daily vs lansoprazole 30 mg twice daily in symptom control of acid regurgitation, epigastric pain, and night-time heartburn in subjects with GERD symptoms resistant to 30 mg daily therapy of lansoprazole
Time frame: Heartburn symptoms collected on diary card daily
To evaluate the use of supplementary antacids (as heartburn rescue therapy) in subjects treated with esomeprazole magnesium 40 mg once daily versus lansoprazole 30 mg twice daily
Time frame: Heartburn symptoms collected on diary card daily
To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily.
Time frame: Ongoing Adverse event collection
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 21 Jan 2011.
Related trials for Heartburn
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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 and Lansoprazole in people with Heartburn and Gastroesophageal Reflux Disease, 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 21 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 clinical efficacy of esomeprazole magnesium 40mg once daily versus lansoprazole 30 mg twice daily in symptom control of heartburn in subjects with heartburn symptoms resistant to 30 mg once daily therapy of lansoprazole. (time frame: Heartburn symptoms collected on diary card daily). 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 21 Jan 2011.