Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

NCT00444275 | Completed Phase 4 Results

• 2 other identifiers: D9612L00111EudraCT No: 2006-002867-19
• Study Type: interventional
• Target: 3,029
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GERD

Keywords

Gastroesophageal Reflux Disease; Acid Reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).

  4 weeks

• Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase

  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)

  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

  16 weeks

• 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

Study Arms (5)

Esomeprazole 20 mg Once Daily (initial phase)

EXPERIMENTAL

Drug: esomeprazole (Nexium®)

Esomeprazole 40 mg Once Daily (initial phase)

EXPERIMENTAL

Drug: esomeprazole (Nexium®)

Esomeprazole 20 mg Once Daily (Maintenance Phase)

EXPERIMENTAL

Drug: esomeprazole (Nexium®)

Esomeprazole 20 mg on Demand (Maintenance Phase)

EXPERIMENTAL

Drug: esomeprazole (Nexium®)

Antacid Treatment (Maintenance Phase)

EXPERIMENTAL

Drug: Xolaam®

Interventions

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

Esomeprazole 20 mg Once Daily (Maintenance Phase); Esomeprazole 20 mg Once Daily (initial phase); Esomeprazole 20 mg on Demand (Maintenance Phase); Esomeprazole 40 mg Once Daily (initial phase)

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

Antacid Treatment (Maintenance Phase)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Rouen, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Planned number of patients not reached: statistical analysis plan revised,comparisons between treatment arms performed globally (No stratified analysis). Safety pop=3032-3 incorrect enrolments (withdrawals at V2) with no information on ttmt received

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• AstraZeneca France Medical Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 11, 2012
• Results First Posted: December 11, 2012

Record last verified: 2012-11

Locations

FR (1)