Trial Outcomes & Findings for Reflux Esophagitis Phase III Study (Maintenance Treatment) (NCT NCT00634114)

Last Updated: 2010-06-17

Results Overview

Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

540 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2010-06-17

Participant Flow

Enrolment 8Jan08-19May09. 564 randomised participants, 563 in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy. SAS for summaries of safety. 1 pt. in Omep. 10 mg excluded as they took no investigational drug. Nos. for gender were 188 in Esom. 20 mg, 188 in Esom. 10 mg and 187 in Omep. 20 mg.

Out of 578 enrolled participants, 564 participants were randomised and 14 participants were not randomised. The reasons of no randomisation were 'Incorrect enrolment' (11 participants) and 'Voluntary discontinuation by participant' (3 participants).

Participant milestones

Participant milestones
Measure	Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg Omeprazole 10 mg once daily
Overall Study STARTED	188	189	187
Overall Study COMPLETED	160	154	148
Overall Study NOT COMPLETED	28	35	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg Omeprazole 10 mg once daily
Overall Study Adverse Event	6	8	3
Overall Study Withdrawal by Subject	9	6	11
Overall Study Lost to Follow-up	0	0	1
Overall Study Protocol Violation	3	3	1
Overall Study Pregnancy	1	0	0
Overall Study Incorrect enrolment	0	1	0
Overall Study Recurrence of reflux esophagitis	5	15	21
Overall Study Difficult to continue	3	1	1
Overall Study Other reason	1	1	1

Baseline Characteristics

Reflux Esophagitis Phase III Study (Maintenance Treatment)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Esomeprazole 20 mg n=188 Participants Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg n=189 Participants Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg n=187 Participants Omeprazole 10 mg once daily	Total n=564 Participants Total of all reporting groups
Age, Customized <65	131 Participants n=5 Participants	131 Participants n=7 Participants	137 Participants n=5 Participants	399 Participants n=4 Participants
Age, Customized 65-74	45 Participants n=5 Participants	41 Participants n=7 Participants	38 Participants n=5 Participants	124 Participants n=4 Participants
Age, Customized >=75	12 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	40 Participants n=4 Participants
Age, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex/Gender, Customized Female	46 Participants n=5 Participants	51 Participants n=7 Participants	42 Participants n=5 Participants	139 Participants n=4 Participants
Sex/Gender, Customized Male	142 Participants n=5 Participants	147 Participants n=7 Participants	145 Participants n=5 Participants	434 Participants n=4 Participants
Sex/Gender, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Outcome measures

Outcome measures
Measure	Experimental: Esomeprazole 20 mg n=188 Participants Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg n=188 Participants Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg n=187 Participants Omeprazole 10 mg once daily
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.	174 Participants	166 Participants	156 Participants

SECONDARY outcome

Timeframe: up to 4 weeks

Outcome measures

Outcome measures
Measure	Experimental: Esomeprazole 20 mg n=188 Participants Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg n=188 Participants Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg n=187 Participants Omeprazole 10 mg once daily
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment	184 Participants	180 Participants	171 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Outcome measures

Outcome measures
Measure	Experimental: Esomeprazole 20 mg n=188 Participants Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg n=188 Participants Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg n=187 Participants Omeprazole 10 mg once daily
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment	179 Participants	172 Participants	163 Participants

Adverse Events

Experimental: Esomeprazole 20 mg

Serious events: 5 serious events

Other events: 71 other events

Deaths: 0 deaths

Experimental: Esomeprazole 10 mg

Serious events: 4 serious events

Other events: 69 other events

Deaths: 0 deaths

Comparator: Omeprazole 10 mg

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Esomeprazole 20 mg n=188 participants at risk Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg n=188 participants at risk Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg n=187 participants at risk Omeprazole 10 mg once daily
Gastrointestinal disorders Colonic polyp	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Oesophagitis	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Constipation	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Cardiac disorders Tachyarrhythmia	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.

Other adverse events

Other adverse events
Measure	Experimental: Esomeprazole 20 mg n=188 participants at risk Esomeprazole 20 mg once daily	Experimental: Esomeprazole 10 mg n=188 participants at risk Esomeprazole 10 mg once daily	Comparator: Omeprazole 10 mg n=187 participants at risk Omeprazole 10 mg once daily
Infections and infestations Nasopharyngitis	16.5% 31/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	19.7% 37/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	16.6% 31/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Infections and infestations Upper respiratory tract infection	2.1% 4/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Abdominal pain upper	5.9% 11/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	1.6% 3/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.1% 4/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Diarrhoea	2.1% 4/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	3.7% 7/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	3.7% 7/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Gastric polyps	1.6% 3/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.1% 4/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 2/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	1.1% 2/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.7% 5/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Constipation	1.1% 2/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.1% 4/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.1% 4/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Investigations Blood creatine phosphokinase increased	2.7% 5/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.7% 5/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	1.1% 2/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Investigations Blood pressure increased	0.53% 1/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.7% 5/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Injury, poisoning and procedural complications Contusion	2.7% 5/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.00% 0/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	1.1% 2/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 3/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	2.1% 4/188 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.	0.53% 1/187 1 participant was excluded in Esomeprazole 10 mg as they did not take any investigational drug.

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