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

NCT01874535 | Completed Phase 4 Results DMC

• 1 other identifier: GERD A and B
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

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

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

GERD Los Angeles A and B-4 week group

ACTIVE COMPARATOR

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

Drug: Esomeprazole 40 mg

GERD Los Angeles A and B-8-week group

ACTIVE COMPARATOR

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

Drug: Esomeprazole 40 mg

Interventions

Esomeprazole 40 mg DRUG

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

Also known as: Nexium 40mg

GERD Los Angeles A and B-4 week group; GERD Los Angeles A and B-8-week group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Seng-Kee Chuah

Kaohsiung City, 833, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 25245625 DERIVED

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The trial was performed in a single country

Results Point of Contact

• Title: Dr. Seng-Kee Chuah and Dr. Wei-Chen Tai
• Organization: Kaohsiung Chang Gung Memorial Hospital, Taiwan

chuahsk@seed.net.tw

886-975056007

Study Officials

• Seng-Kee Chuah, M.D

  Kaohsiung Chang Gung Memorial Hospital,Taiwan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: June 11, 2013
• Study Start: June 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 4, 2018
• Results First Posted: September 4, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)