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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

20 mg q.d. (quaque die) once a day dosing for 8 weeks

20 mg q.d. (quaque die) once a day dosing for 2 weeks

To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.

Esomeprazole treatment co-diagnosed Non erosive reflux disease (NERD) and chronic gastritis patients

A multicenter, randomized, open-label Phase IV study exploring symptom  control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks  esomeprazole treatment regimen.

20mg  Esomeprazole once daily, 8 weeks  and  24 weeks on-demand treatment

20mg  Esomeprazole once daily, 2 weeks  and  24 weeks follow up

Research Site

A multicenter, randomized, open-label Phase IV study exploring symptom  control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks  esomeprazole treatment regimen

GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.

Age Categorical

Age Continuous

Gender, Male/Female

Region of Enrollment

MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment

Symptom control rate at 24 weeks assessed by Gerd Q questionnaire.

Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled
during maintenance treatment / follow-up period.

Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.

The success rate in whole study duration.

Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.
Time to first relapse is actually the time when 50% of patients had relapse.  Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint

MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.

Time to first relapse.

Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.

ITT was defined as all randomized subjects who took at least one dose of treatment.

Symptom relief rate in 2 treatment regimens.

2 weeks

8 weeks

Symptom Relief Rate after 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.

Number of patients with unscheduled hospital visit(s)

Satisfied

Very satisfied

Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.

Percentage of Patients Satisfaction

Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment

Arms	Assigned Interventions
Active Comparator: Esomeprazole 8 weeks treatment 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Drug: Esomeprazole 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
Active Comparator: Esomeprazole 2 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 2 weeks	Drug: Esomeprazole 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up

Esomeprazole treatment co-diagnosed Non erosive reflux disease (NERD) and chronic gastritis patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=438&filename=CSR-D9612L00127.pdf

CSR-D9612L00127.pdf

D9612L00127_Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator