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Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients (MAESTRO)

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ClinicalTrials.gov Identifier: NCT00444275
Recruitment Status : Completed
First Posted : March 7, 2007
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

Condition or disease Intervention/treatment Phase
GERD Drug: esomeprazole (Nexium®) Drug: Xolaam® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3029 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: Esomeprazole 20 mg Once Daily (initial phase) Drug: 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
Experimental: Esomeprazole 40 mg Once Daily (initial phase) Drug: 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
Experimental: Esomeprazole 20 mg Once Daily (Maintenance Phase) Drug: 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
Experimental: Esomeprazole 20 mg on Demand (Maintenance Phase) Drug: 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
Experimental: Antacid Treatment (Maintenance Phase) Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. 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 ]

    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.


  2. Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase [ Time Frame: 4 weeks ]
    No possibility to describe as only 2 patients took ASA

  3. 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 ]
    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)

  4. 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 ]
    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)

  5. 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 ]
    Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.

  6. Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire [ Time Frame: Day 0 ]
    May be used to evaluate the severity of symptoms during the initial visit. Not done

  7. Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire [ Time Frame: Day 0 ]

    May be used to offer patients a strategy of treatment during the initial phase and in the long term.

    Not done


  8. Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) [ Time Frame: Week 4 ]
    May be used to define the success of treatment. Not done


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444275


Locations
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France
Research Site
Rouen, France
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca France Medical Director, MD AstraZeneca
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00444275    
Other Study ID Numbers: D9612L00111
EudraCT No: 2006-002867-19
First Posted: March 7, 2007    Key Record Dates
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012
Last Verified: November 2012
Keywords provided by AstraZeneca:
Gastroesophageal Reflux Disease
Acid Reflux
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action