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

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

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

Study Overview

• Status: Completed
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: Esomeprazole 40 mg

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 Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Seng-Kee Chuah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GERD Los Angeles A and B-4 week group; Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group	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; Other Names: Nexium 40mg
Active Comparator: GERD Los Angeles A and B-8-week group; Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group	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; Other Names: Nexium 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Seng-Kee Chuah, M.D, Kaohsiung Chang Gung Memorial Hospital,Taiwan

Publications and helpful links

General Publications

• Hsu PI, Lu CL, Wu DC, Kuo CH, Kao SS, Chang CC, Tai WC, Lai KH, Chen WC, Wang HM, Cheng JS, Tsai TJ, Chuah SK. Eight weeks of esomeprazole therapy reduces symptom relapse, compared with 4 weeks, in patients with Los Angeles grade A or B erosive esophagitis. Clin Gastroenterol Hepatol. 2015 May;13(5):859-66.e1. doi: 10.1016/j.cgh.2014.09.033. Epub 2014 Sep 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 4, 2012
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: GERD A and B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be shared in July 2017