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Completed

NCT Number: NCT00444275

Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: MAESTRO

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2007
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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