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

Erosive Esophagitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874535
• Other study ID #: GERD A and B
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

Drug:
• Esomeprazole 40 mg
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

Locations

Country	Name	City	State
Taiwan	Seng-Kee Chuah	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rates of Complete Symptom Relief	Rate of complete symptom relief (CSR) at the end of initial treatment phase	at the 20 weeks after the end of initial treatment.