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

Primary Purpose

Erosive Esophagitis

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Esomeprazole 40 mg

About this trial

This is an interventional treatment trial for Erosive Esophagitis

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seng-Kee Chuah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

GERD Los Angeles A and B-4 week group

GERD Los Angeles A and B-8-week group

Arm Description

Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group

Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group

Outcomes

Primary Outcome Measures

The Rates of Complete Symptom Relief

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01874535

First Posted

November 4, 2012

Last Updated

November 21, 2017

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01874535

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erosive Esophagitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

408 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GERD Los Angeles A and B-4 week group

Arm Type

Active Comparator

Arm Description

Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group

Arm Title

GERD Los Angeles A and B-8-week group

Arm Type

Active Comparator

Arm Description

Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group

Intervention Type

Drug

Intervention Name(s)

Esomeprazole 40 mg

Other Intervention Name(s)

Nexium 40mg

Intervention Description

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

Primary Outcome Measure Information:

Title

The Rates of Complete Symptom Relief

Description

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

Time Frame

at the 20 weeks after the end of initial treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seng-Kee Chuah, M.D

Organizational Affiliation

Kaohsiung Chang Gung Memorial Hospital,Taiwan

Official's Role

Study Chair

Facility Information:

Facility Name

Seng-Kee Chuah

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data will be shared in July 2017

Citations:

PubMed Identifier

25245625

Citation

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.

Results Reference

derived

Learn more about this trial

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

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