Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

Phase 4

Completed

• Conditions: GERD
• Interventions: Drug: esomeprazole (Nexium®); Drug: Xolaam®

• Registration Number: NCT00444275
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-05
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-07
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2010-03-29
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-14
• Last Update Submitted: 2012-11-14
• Results First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3029

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole 40 mg Once Daily (initial phase)	esomeprazole (Nexium®)	-
Esomeprazole 20 mg Once Daily (initial phase)	esomeprazole (Nexium®)	-
Esomeprazole 20 mg Once Daily (Maintenance Phase)	esomeprazole (Nexium®)	-
Esomeprazole 20 mg on Demand (Maintenance Phase)	esomeprazole (Nexium®)	-
Antacid Treatment (Maintenance Phase)	Xolaam®	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Three Strategies of Long-term Treatment	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

Name	Time	Method
Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).	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.
Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase	4 weeks	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)	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)
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	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)
Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study	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.
Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire	Day 0	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)	Week 4	May be used to define the success of treatment. Not done

Trial Locations

Locations (1)

Research Site; 🇫🇷 Rouen, France