Phase 4
N=408
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Erosive Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT01874535 ↗Enrolled (actual)
408
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: The Rates of Complete Symptom Relief — 152; 157 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Esomeprazole 40 mg (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rates of Complete Symptom Relief |
152; 157 | <0.05 sig |
Summary
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Eligibility Criteria
Inclusion Criteria
- patients between the ages of 15 and 80 years
- with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
- who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.
Exclusion Criteria
- coexistence of peptic ulcer or gastrointestinal malignancies,
- pregnancy,
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
- previous gastric surgery,
- allergy to esomeprazole,
- symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
- equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Data sourced from ClinicalTrials.gov (NCT01874535). 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.