Trial Outcomes & Findings for Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients (NCT NCT01119768)

NCT ID: NCT01119768

Last Updated: 2012-09-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 305 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2012-09-28

Participant Flow

Three hundred and five patients, out of the 311 patients who signed the informed consent, were randomized to receive 8 weeks (n=154) or 2 weeks (n=151) of esomeprazole treatment.

Participant milestones

Measure	Esomeprazole 8 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Treatment Period STARTED	154	151
Treatment Period COMPLETED	136	126
Treatment Period NOT COMPLETED	18	25
Follow-up STARTED	136	124
Follow-up COMPLETED	135	122
Follow-up NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Esomeprazole 8 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Treatment Period Lack of Efficacy	18	25

Baseline Characteristics

Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients

Baseline characteristics by cohort

Measure	Esomeprazole 8 Weeks Treatment n=154 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=151 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks	Total n=305 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	143 Participants n=5 Participants	140 Participants n=7 Participants	283 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age Continuous	45.9 years STANDARD_DEVIATION 12.72 • n=5 Participants	44.9 years STANDARD_DEVIATION 13.12 • n=7 Participants	45.4 years STANDARD_DEVIATION 12.91 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	54 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	97 Participants n=7 Participants	171 Participants n=5 Participants
Region of Enrollment China	154 participants n=5 Participants	151 participants n=7 Participants	305 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

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

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.

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=136 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=126 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.	94.9 percentage of participants	87.3 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after end of treatment

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

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.

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=154 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=151 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
The Success Rate in Whole Study Duration.	83.8 percentage of participants	72.8 percentage of participants

SECONDARY outcome

Timeframe: From baseline to 24 weeks after end of treatment

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

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

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=136 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=126 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Time to First Relapse.	NA days Interval 35.0 to More than half of patients remained relapse free.	57 days Interval 12.0 to 174.0

SECONDARY outcome

Timeframe: 8 weeks for arm 1, 2 weeks for arm 2

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

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.

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=154 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=151 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Symptom Relief Rate in 2 Treatment Regimens.	88.3 percentage of participans	83.4 percentage of participans

SECONDARY outcome

Timeframe: 2 and 8 weeks

Population: ITT in 8 weeks treatment group

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.

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=154 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. 2 weeks	54.5 percentage of participants	—
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. 8 weeks	88.3 percentage of participants	—

SECONDARY outcome

Timeframe: from baseline to week 24 after end of treatment

Population: MITT

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=136 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=126 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Number of Patients With Unscheduled Hospital Visit(s)	59 participants	80 participants

SECONDARY outcome

Timeframe: 24 weeks after end of treatment

Population: MITT

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

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=136 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=126 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Percentage of Patients Satisfaction Satisfied	100 percentage of participants	96 percentage of participants
Percentage of Patients Satisfaction Very satisfied	48.5 percentage of participants	24.6 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=136 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=126 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire	80.1 percentage of participants	75.4 percentage of participants

SECONDARY outcome

Timeframe: 16 weeks

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

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.

Outcome measures

Measure	Esomeprazole 8 Weeks Treatment n=136 Participants 20 mg q.d. (quaque die) once a day dosing for 8 weeks	Esomeprazole 2 Weeks Treatment n=126 Participants 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire	85.3 percentage of participants	80.2 percentage of participants

Adverse Events

Esomeprazole 8 Weeks Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Esomeprazole 2 Weeks Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerard Lynch

AstraZeneca

Email: az_trials_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER