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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Erosive Esophagitis

Treatments: Drug: Esomeprazole 40 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01874535

GERD A and B

Details and patient eligibility

About

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

Full 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

Enrollment: 408 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

GERD Los Angeles A and B-4 week group

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole 40 mg

GERD Los Angeles A and B-8-week group

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole 40 mg