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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01119768
• Collaborator: (none)
• Enrollment: 305
• Locations: 8
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 38.1
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non Erosive Reflux Disease; Chronic Gastritis	Drug: Esomeprazole; Drug: Esomeprazole	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 305 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. [24 weeks]

   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.

Secondary Outcome Measures

1. The Success Rate in Whole Study Duration. [24 weeks after end 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.

2. Time to First Relapse. [From baseline to 24 weeks after end of 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

3. Symptom Relief Rate in 2 Treatment Regimens. [8 weeks for arm 1, 2 weeks for arm 2]

   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.

4. Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. [2 and 8 weeks]

   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.

5. Number of Patients With Unscheduled Hospital Visit(s) [from baseline to week 24 after end of treatment]

6. Percentage of Patients Satisfaction [24 weeks after end of treatment]

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

7. Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire [8 weeks]

   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.

8. Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire [16 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Heartburn and/or regurgitation symptoms last for at least 3 months

• Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8

Exclusion Criteria:

• Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded

• If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Guangzhou	Guangdong	China
2	Research Site	Wuhan	Hubei	China
3	Research Site	Nanjing	Jiangsu	China
4	Research Site	Jinan	Shandong	China
5	Research Site	Xian	Shanxi	China
6	Research Site	Hangzhou	Zhejiang	China
7	Research Site	Beijin		China
8	Research Site	Shanghai		China

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Wenyu Guo, AstraZeneca China MC
• Principal Investigator: Prof. Yuan Yaozong, Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01119768
• Other Study ID Numbers: D9612L00127
• First Posted: May 10, 2010
• Last Update Posted: Sep 28, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by AstraZeneca: GI; Nexium; Phase IV; Co-diagnosed NERD
• Additional relevant MeSH terms: Gastroesophageal Reflux; Gastritis; Gastritis, Atrophic; Esomeprazole

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Period Title: Treatment Period
STARTED	154	151
COMPLETED	136	126
NOT COMPLETED	18	25
Period Title: Treatment Period
STARTED	136	124
COMPLETED	135	122
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment	Total
Arm/Group Description	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	Total of all reporting groups
Overall Participants	154	151	305
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	143 92.9%	140 92.7%	283 92.8%
>=65 years	11 7.1%	11 7.3%	22 7.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (12.72)	44.9 (13.12)	45.4 (12.91)
Sex: Female, Male (Count of Participants)
Female	80 51.9%	54 35.8%	134 43.9%
Male	74 48.1%	97 64.2%	171 56.1%
Region of Enrollment (participants) [Number]
China	154 100%	151 100%	305 100%

Outcome Measures

1. Primary Outcome

Title	Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	136	126
Number [percentage of participants]	94.9 61.6%	87.3 57.8%

2. Secondary Outcome

Title	The Success Rate in Whole Study Duration.
Description	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.
Time Frame	24 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	154	151
Number [percentage of participants]	83.8 54.4%	72.8 48.2%

3. Secondary Outcome

Title	Time to First Relapse.
Description	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
Time Frame	From baseline to 24 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	136	126
Median (Inter-Quartile Range) [days]	NA	57

4. Secondary Outcome

Title	Symptom Relief Rate in 2 Treatment Regimens.
Description	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.
Time Frame	8 weeks for arm 1, 2 weeks for arm 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	154	151
Number [percentage of participans]	88.3	83.4

5. Secondary Outcome

Title	Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.
Description	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.
Time Frame	2 and 8 weeks

Outcome Measure Data

Analysis Population Description

ITT in 8 weeks treatment group

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	154	0
2 weeks	54.5 35.4%
8 weeks	88.3 57.3%

6. Secondary Outcome

Title	Number of Patients With Unscheduled Hospital Visit(s)
Time Frame	from baseline to week 24 after end of treatment

Outcome Measure Data

Analysis Population Description

MITT

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	136	126
Number [participants]	59 38.3%	80 53%

7. Secondary Outcome

Title	Percentage of Patients Satisfaction
Description	Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.
Time Frame	24 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

MITT

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	136	126
Satisfied	100 64.9%	96 63.6%
Very satisfied	48.5 31.5%	24.6 16.3%

8. Secondary Outcome

Title	Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	136	126
Number [percentage of participants]	80.1 52%	75.4 49.9%

9. Secondary Outcome

Title	Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire
Description	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.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Esomeprazole 8 Weeks Treatment	Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
Measure Participants	136	126
Number [percentage of participants]	85.3 55.4%	80.2 53.1%

Adverse Events

Time Frame	From baseline to 24 weeks after treatment.
Arm/Group Title	Esomeprazole 8 Weeks Treatment		Esomeprazole 2 Weeks Treatment
Arm/Group Description	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
All Cause Mortality
	Esomeprazole 8 Weeks Treatment		Esomeprazole 2 Weeks Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Esomeprazole 8 Weeks Treatment		Esomeprazole 2 Weeks Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/151 (0%)
Other (Not Including Serious) Adverse Events
	Esomeprazole 8 Weeks Treatment		Esomeprazole 2 Weeks Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/151 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.