Trial Outcomes & Findings for Reflux Esophagitis Phase III Study (Initial Treatment) (NCT NCT00633932)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

602 participants

Primary outcome timeframe

8 weeks

Results posted on

2010-12-20

Participant Flow

First subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.

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).

Participant milestones

Participant milestones
Measure	Experimental: Esomeprazole 40mg Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg Omeprazole 20mg once daily
Overall Study STARTED	191	190	191
Overall Study COMPLETED	179	176	180
Overall Study NOT COMPLETED	12	14	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Esomeprazole 40mg Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg Omeprazole 20mg once daily
Overall Study Adverse Event	1	3	4
Overall Study Withdrawal by Subject	3	9	1
Overall Study Lost to Follow-up	1	0	2
Overall Study Protocol Violation	5	2	3
Overall Study Physician Decision	0	0	1
Overall Study Doctor's judgement	1	0	0
Overall Study Moved Away	1	0	0

Baseline Characteristics

Reflux Esophagitis Phase III Study (Initial Treatment)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Esomeprazole 40mg n=191 Participants Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg n=190 Participants Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg n=191 Participants Omeprazole 20mg once daily	Total n=572 Participants Total of all reporting groups
Age, Customized < 65 years	127 Participants n=5 Participants	135 Participants n=7 Participants	126 Participants n=5 Participants	388 Participants n=4 Participants
Age, Customized 65 - 74 years	47 Participants n=5 Participants	36 Participants n=7 Participants	44 Participants n=5 Participants	127 Participants n=4 Participants
Age, Customized >= 75 years	16 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	54 Participants n=4 Participants
Age, Customized Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex/Gender, Customized Male	139 Participants n=5 Participants	137 Participants n=7 Participants	134 Participants n=5 Participants	410 Participants n=4 Participants
Sex/Gender, Customized Female	51 Participants n=5 Participants	52 Participants n=7 Participants	56 Participants n=5 Participants	159 Participants n=4 Participants
Sex/Gender, Customized Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Experimental: Esomeprazole 40mg n=190 Participants Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg n=189 Participants Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg n=190 Participants Omeprazole 20mg once daily
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".	171 participants	165 participants	166 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Experimental: Esomeprazole 40mg n=190 Participants Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg n=189 Participants Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg n=190 Participants Omeprazole 20mg once daily
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	141 participants	147 participants	143 participants

Adverse Events

Experimental: Esomeprazole 40mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Experimental: Esomeprazole 20mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Comparator: Omeprazole 20mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Esomeprazole 40mg n=190 participants at risk Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg n=189 participants at risk Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg n=190 participants at risk Omeprazole 20mg once daily
Infections and infestations Bronchopneumonia	0.00% 0/190 One patient for each treatment group did not take any investigational product.	0.53% 1/189 One patient for each treatment group did not take any investigational product.	0.00% 0/190 One patient for each treatment group did not take any investigational product.
Infections and infestations Gastroenteritis	0.00% 0/190 One patient for each treatment group did not take any investigational product.	0.00% 0/189 One patient for each treatment group did not take any investigational product.	0.53% 1/190 One patient for each treatment group did not take any investigational product.
General disorders Influenza Like Illness	0.00% 0/190 One patient for each treatment group did not take any investigational product.	0.53% 1/189 One patient for each treatment group did not take any investigational product.	0.00% 0/190 One patient for each treatment group did not take any investigational product.

Other adverse events

Other adverse events
Measure	Experimental: Esomeprazole 40mg n=190 participants at risk Esomeprazole 40mg once daily	Experimental: Esomeprazole 20mg n=189 participants at risk Esomeprazole 20mg once daily	Comparator: Omeprazole 20mg n=190 participants at risk Omeprazole 20mg once daily
Gastrointestinal disorders Diarrhoea	1.1% 2/190 One patient for each treatment group did not take any investigational product.	1.6% 3/189 One patient for each treatment group did not take any investigational product.	3.2% 6/190 One patient for each treatment group did not take any investigational product.
Infections and infestations Nasopharyngitis	5.3% 10/190 One patient for each treatment group did not take any investigational product.	3.2% 6/189 One patient for each treatment group did not take any investigational product.	5.3% 10/190 One patient for each treatment group did not take any investigational product.

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study withiout AZ approval before this study was completed.
Publication restrictions are in place

Restriction type: OTHER