Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

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

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Drug: esomeprazole (Nexium®)
* Drug: Xolaam®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole 20 mg Once Daily (initial phase)<br> | Drug: esomeprazole (Nexium®)<br>* 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<br>|
| Experimental: Esomeprazole 40 mg Once Daily (initial phase)<br> | Drug: esomeprazole (Nexium®)<br>* 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<br>|
| Experimental: Esomeprazole 20 mg Once Daily (Maintenance Phase)<br> | Drug: esomeprazole (Nexium®)<br>* 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<br>|
| Experimental: Esomeprazole 20 mg on Demand (Maintenance Phase)<br> | Drug: esomeprazole (Nexium®)<br>* 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<br>|
| Experimental: Antacid Treatment (Maintenance Phase)<br> | Drug: Xolaam®<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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) | 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) | 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. | 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 | 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 | Day 0 | 
| Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) | May be used to define the success of treatment. Not done | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease, Acid Reflux