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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

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Reflux esophagitis Phase III study (Initial treatment)

Research Site

A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of esomeprazole 20 mg and 40 mg once daily oral administration with omeprazole 20 mg once daily oral administration in patients with reflux esophagitis

Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised.  A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

Age, Customized

Gender, Customized

One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.

Number of participants with healing of Reflux Esophagitis (RE) who were graded "O" at Week 8 out of patients who were graded "A, B, C or D" at baseline according to Los Angeles classification".

Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D).  The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised.  A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification

Overall Study

Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects).

Arms	Assigned Interventions
Experimental: 1 Esomeprazole 20mg	Drug: Esomeprazole 20mg once daily Other Name: Nexium
Experimental: 2 Esomeprazole 40mg	Drug: Esomeprazole 40 mg once daily Other Name: Nexium
Active Comparator: 3 Omeprazole 20mg	Drug: Omeprazole 20mg once daily Other Name: Prilosec

Reflux esophagitis Phase III study (Initial treatment)

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=445&filename=CSP-D961HC00002.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=445&filename=CSR-D961HC00002.pdf

CSP-D961HC00002.pdf

CSP-D961HC00002.pdf

CSP-D961HC00002.pdf

CSR-D961HC00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator