Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erosive Esophagitis

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seng-Kee Chuah

Kaohsiung City, 833, Taiwan

About this study

Patients:

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. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.

Outcome parameters:

The main outcome measures

Rate of complete symptom relief (CSR) at the end of initial treatment phase
rate of symptom relapse within 12 weeks after stopping initial therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esomeprazole 40 mg

Drug

Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis

Other names: Nexium 40mg

Primary outcomes

The Rates of Complete Symptom Relief

Time frame: at the 20 weeks after the end of initial treatment.

Rate of complete symptom relief (CSR) at the end of initial treatment phase

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Rates of Complete Symptom Relief,Prevetion of Symptom Relapse and Maintenance of Esophagitis Healing for 4-week Versus 8-week Esomeprazole Therapy Among Los Angeles Grades A and B Erosive Esophagitis

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Jun 11, 2013
Registry last updated: Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed