GERDPhase 4MAESTRONCT00444275
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
A Phase 4 study testing esomeprazole (Nexium®) and Xolaam® in people with GERD, run by AstraZeneca at 1 site in France.
Trial summary
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- GERD
- What is being tested?
- esomeprazole (Nexium®) and Xolaam®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,029 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
Who cannot join
- Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
- A history of severe esophagitis or known other complications, with alarm symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Parallel-group Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
- Conditions
- GERD
- Being tested
- esomeprazole (Nexium®), Xolaam®
- Keywords
- Gastroesophageal Reflux Disease, Acid Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole (Nexium®)Drug
This randomized study was conducted on parallel groups and included two phases:
- One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
- One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Xolaam®Drug
This randomized study was conducted on parallel groups and included two phases:
- One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
- One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 20 mg Once Daily (initial phase) | Experimental | Not described Receives: Drug: esomeprazole (Nexium®) |
| Esomeprazole 40 mg Once Daily (initial phase) | Experimental | Not described Receives: Drug: esomeprazole (Nexium®) |
| Esomeprazole 20 mg Once Daily (Maintenance Phase) | Experimental | Not described Receives: Drug: esomeprazole (Nexium®) |
| Esomeprazole 20 mg on Demand (Maintenance Phase) | Experimental | Not described Receives: Drug: esomeprazole (Nexium®) |
| Antacid Treatment (Maintenance Phase) | Experimental | Not described Receives: Drug: Xolaam® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Three Strategies of Long-term Treatment
Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?
Measured: 16 weeks
Secondary outcomes (8)
Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).
Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator.
The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item.
Measured: 4 weeks
Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase
No possibility to describe as only 2 patients took ASA
Measured: 4 weeks
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)
Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)
Measured: 4 to 16 weeks
Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment
Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression)
Measured: 16 weeks
Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study
Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.
Measured: 12 weeks - maintenance treatment phase
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
May be used to evaluate the severity of symptoms during the initial visit. Not done
Measured: Day 0
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
May be used to offer patients a strategy of treatment during the initial phase and in the long term.
Not done
Measured: Day 0
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)
May be used to define the success of treatment. Not done
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca France Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444275
- Sponsor's protocol ID
- D9612L00111
- Other IDs
- EudraCT No: 2006-002867-19
- Acronym
- MAESTRO
- Status last verified
- Nov 2012
- First submitted
- 5 Mar 2007
- Last updated
- 11 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel-group Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
- ClinicalTrials.gov ID
- NCT00444275
- Acronym / sponsor ID
- MAESTRO / D9612L00111
- Conditions
- GERD
- Keywords
- Gastroesophageal Reflux Disease, Acid Reflux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,029 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Posted 11 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 20 mg Once Daily (initial phase) | Experimental | Drug: esomeprazole (Nexium®) |
| Esomeprazole 40 mg Once Daily (initial phase) | Experimental | Drug: esomeprazole (Nexium®) |
| Esomeprazole 20 mg Once Daily (Maintenance Phase) | Experimental | Drug: esomeprazole (Nexium®) |
| Esomeprazole 20 mg on Demand (Maintenance Phase) | Experimental | Drug: esomeprazole (Nexium®) |
| Antacid Treatment (Maintenance Phase) | Experimental | Drug: Xolaam® |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
Key exclusion criteria (2 listed)
- Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
- A history of severe esophagitis or known other complications, with alarm symptoms
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 (Nexium®)This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed | Drug | Esomeprazole 20 mg Once Daily (Maintenance Phase), Esomeprazole 20 mg Once Daily (initial phase), Esomeprazole 20 mg on Demand (Maintenance Phase), Esomeprazole 40 mg Once Daily (initial phase) |
| Xolaam®This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed | Drug | Antacid Treatment (Maintenance Phase) |
Primary outcome
Efficacy of Three Strategies of Long-term Treatment
Time frame: 16 weeks
Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?
8 secondary outcomes
Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).
Time frame: 4 weeks
Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase
Time frame: 4 weeks
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)
Time frame: 4 to 16 weeks
Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment
Time frame: 16 weeks
Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study
Time frame: 12 weeks - maintenance treatment phase
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
Time frame: Day 0
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
Time frame: Day 0
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for GERD
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Active, not recruitingObservational study
RETHINK REFLUX Registry
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Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
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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.
AstraZeneca France Medical Director, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole (Nexium®) and Xolaam® in people with GERD, run by AstraZeneca at 1 site in France.
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 2 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Yes. Results are posted in the registry (first posted 11 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Three Strategies of Long-term Treatment (time frame: 16 weeks). 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 11 Dec 2012.