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

Phase 4

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: Esomeprazole 40 mg

• Registration Number: NCT01874535
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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

Detailed Description

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

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

2. rate of symptom relapse within 12 weeks after stopping initial therapy

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-11-04
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-06
• Results First Submitted: 2017-06-16
• Results First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Results First Posted: 2018-09-04
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GERD Los Angeles A and B-4 week group	Esomeprazole 40 mg	Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group
GERD Los Angeles A and B-8-week group	Esomeprazole 40 mg	Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group

Primary Outcome Measures

Name	Time	Method
The Rates of Complete Symptom Relief	at the 20 weeks after the end of initial treatment.	Rate of complete symptom relief (CSR) at the end of initial treatment phase

Trial Locations

Locations (1)

Seng-Kee Chuah; 🇨🇳 Kaohsiung, Taiwan