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

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ClinicalTrials.gov Identifier: NCT01874535
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Wei-Chen Tai M.D., Chang Gung Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: Esomeprazole 40 mg Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Nexium 40mg




Primary Outcome Measures :
  1. The Rates of Complete Symptom Relief [ Time Frame: at the 20 weeks after the end of initial treatment. ]
    Rate of complete symptom relief (CSR) at the end of initial treatment phase



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874535


Locations
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Taiwan
Seng-Kee Chuah
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Seng-Kee Chuah, M.D Kaohsiung Chang Gung Memorial Hospital,Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wei-Chen Tai M.D., Attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01874535     History of Changes
Other Study ID Numbers: GERD A and B
First Posted: June 11, 2013    Key Record Dates
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared in July 2017
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action