Phase 4
N=3,029
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
GERD
Bottom Line
View on ClinicalTrials.gov: NCT00444275 ↗Enrolled (actual)
3,029
Serious AEs
0.3%
Results posted
Dec 2012
Primary outcome: Primary: Efficacy of Three Strategies of Long-term Treatment — 10.6; 7.8; 43 Percentage of participants with failure
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- esomeprazole (Nexium®) (Drug); Xolaam® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Three Strategies of Long-term Treatment |
10.6; 7.8; 43 | — |
| SECONDARY Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). |
3.7; 2.3 | — |
| SECONDARY Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase |
— | — |
| 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) |
0.12; 0.04; -0.22 | — |
| 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 |
9.8; 9.3; 43.7 | — |
| SECONDARY Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study |
5; 4; 15 | — |
| SECONDARY Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire |
— | — |
| SECONDARY Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire |
— | — |
| SECONDARY Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) |
— | — |
Summary
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00444275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.