Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

GERD Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444275
• Other study ID #: D9612L00111
• Secondary ID: EudraCT No: 2006
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2007
• Last updated: November 14, 2012
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3029
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• GERD

Intervention

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
• 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

Locations

Country	Name	City	State
France	Research Site	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)	May be used to define the success of treatment. Not done	Week 4	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US