Back to resultsNexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients (MAESTRO)
Primary Purpose
GERD
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
esomeprazole (Nexium®)
Xolaam®
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring Gastroesophageal Reflux Disease, Acid Reflux
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Esomeprazole 20 mg Once Daily (initial phase)
Esomeprazole 40 mg Once Daily (initial phase)
Esomeprazole 20 mg Once Daily (Maintenance Phase)
Esomeprazole 20 mg on Demand (Maintenance Phase)
Antacid Treatment (Maintenance Phase)
Arm Description
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
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.
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
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)
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)
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.
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
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
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)
May be used to define the success of treatment. Not done
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444275
Brief Title
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
Acronym
MAESTRO
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
Gastroesophageal Reflux Disease, Acid Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3029 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole 20 mg Once Daily (initial phase)
Arm Type
Experimental
Arm Title
Esomeprazole 40 mg Once Daily (initial phase)
Arm Type
Experimental
Arm Title
Esomeprazole 20 mg Once Daily (Maintenance Phase)
Arm Type
Experimental
Arm Title
Esomeprazole 20 mg on Demand (Maintenance Phase)
Arm Type
Experimental
Arm Title
Antacid Treatment (Maintenance Phase)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
esomeprazole (Nexium®)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Xolaam®
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy of Three Strategies of Long-term Treatment
Description
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?
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).
Description
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.
Time Frame
4 weeks
Title
Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase
Description
No possibility to describe as only 2 patients took ASA
Time Frame
4 weeks
Title
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)
Description
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)
Time Frame
4 to 16 weeks
Title
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
Description
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)
Time Frame
16 weeks
Title
Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study
Description
Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.
Time Frame
12 weeks - maintenance treatment phase
Title
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
Description
May be used to evaluate the severity of symptoms during the initial visit. Not done
Time Frame
Day 0
Title
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
Description
May be used to offer patients a strategy of treatment during the initial phase and in the long term.
Not done
Time Frame
Day 0
Title
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)
Description
May be used to define the success of treatment. Not done
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca France Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Rouen
Country
France
12. IPD Sharing Statement
Learn more about this trial
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
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