NEON: A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00734097
• Collaborator: (none)
• Enrollment: 314
• Locations: 10
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 31.4
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole 40 mg; Procedure: Physical Exam; Other: Quality of Life Questionnaires; Procedure: pregnancy test, if applicable	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 314 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nexium 40 mgs	Drug: Esomeprazole 40 mg; Once a day; Other Names: Nexium ; Procedure: Physical Exam; every visit; Other: Quality of Life Questionnaires; every visit; Procedure: pregnancy test, if applicable; as needed

Outcome Measures

Primary Outcome Measures

1. Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment [At Baseline and 8 weeks]

   Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline

Secondary Outcome Measures

1. Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment [At Baseline and 4 weeks]

   Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.

2. Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment [At Baseline and 8 weeks]

   Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

3. Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment [At Baseline and 4 weeks]

   Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

4. Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment. [At Baseline and 4 weeks.]

   Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

5. Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment. [At Baseline and 8 weeks.]

   Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

6. Change in Frequency of Epigastric Pain After 4 Weeks of Treatment [At Baseline and 4 weeks]

   Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

7. Change in Frequency of Epigastric Pain After 8 Weeks of Treatment [At Baseline and 8 weeks]

   Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).

8. Change in Severity of Epigastric Pain After 8 Weeks of Treatment [At Baseline and 8 weeks]

   Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

9. Change in Severity of Epigastric Pain After 4 Weeks of Treatment [At Baseline and 4 weeks]

   Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

10. Change in Severity of Acid Regurgitation After 8 Weeks of Treatment [At Baseline and 8 weeks]

    Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

11. Change in Severity of Acid Regurgitation After 4 Weeks of Treatment [At Baseline and 4 weeks]

    Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor

• informed consent

• over 18 years of age

Exclusion Criteria:

• Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study

• More than 1 other course of PPI treatment in the previous 12 month

• previous use of esomeprazole

• presence of alarm symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Buenos Aires		Argentina
2	Research Site	Santiago de Chile		Chile
3	Research Site	Temuco		Chile
4	Research Site	Vina del Mar		Chile
5	Research Site	Barranquilla		Colombia
6	Research Site	Bogota		Colombia
7	Research Site	Medellin		Colombia
8	Research Site	Barquisimeto		Venezuela
9	Research Site	Caracas		Venezuela
10	Research Site	San Cristobal		Venezuela

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00734097
• Other Study ID Numbers: D9612L00116; NEON
• First Posted: Aug 13, 2008
• Last Update Posted: Oct 10, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by AstraZeneca: heartburn; reflux; proton; pump; inhibitor
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Esomeprazole

Study Results

Participant Flow

Recruitment Details	Participants with persisting symptoms of Gastroesophageal Reflux Disease (GORD) despite previous treatment with a full dose proton pump inhibitor were enrolled across the Argentina (6 sites), Chile (3 sites) Colombia (9 sites) and Venezuela (2 sites).
Pre-assignment Detail	All participants received 8-weeks open label esomeprazole treatment.

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Period Title: Screening
STARTED	337
COMPLETED	317
NOT COMPLETED	20
Period Title: Screening
STARTED	317
Safety Analysis	317
Full Analysis	311
Per Protocol	301
COMPLETED	301
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Overall Participants	311
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42.7 (14.3)
Sex: Female, Male (Count of Participants)
Female	212 68.2%
Male	99 31.8%

Outcome Measures

1. Primary Outcome

Title	Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Description	Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
Time Frame	At Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Days per week with symptoms]	-3.44 (2.35)

2. Secondary Outcome

Title	Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Description	Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
Time Frame	At Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Days per week with symptoms]	-3.08 (2.32)

3. Secondary Outcome

Title	Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
Description	Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Units of scale]	-1.56 (1.01)

4. Secondary Outcome

Title	Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
Description	Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Units on scale]	-1.34 (1.03)

5. Secondary Outcome

Title	Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
Description	Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Days per week with symptoms]	-2.95 (2.42)

6. Secondary Outcome

Title	Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
Description	Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 8 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Days per week with symptoms]	-3.28 (2.51)

7. Secondary Outcome

Title	Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
Description	Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Days per week with pain]	-2.77 (2.5)

8. Secondary Outcome

Title	Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
Description	Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).
Time Frame	At Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Days per week with pain]	-3.16 (2.52)

9. Secondary Outcome

Title	Change in Severity of Epigastric Pain After 8 Weeks of Treatment
Description	Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Units of scale]	-1.34 (1.1)

10. Secondary Outcome

Title	Change in Severity of Epigastric Pain After 4 Weeks of Treatment
Description	Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Units of scale]	-1.17 (1.1)

11. Secondary Outcome

Title	Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
Description	Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Units of scale]	-1.51 (1.09)

12. Secondary Outcome

Title	Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
Description	Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame	At Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
Measure Participants	311
Mean (Standard Deviation) [Units of scale]	-1.31 (1.06)

Adverse Events

Arm/Group Title	Esomeprazole 40mg, Daily
Arm/Group Description	Open-label daily esomeprazole 40 mg, daily for 8 weeks
All Cause Mortality
	Esomeprazole 40mg, Daily
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Esomeprazole 40mg, Daily
	Affected / at Risk (%)	# Events
Total	4/317 (1.3%)
Cardiac disorders
Dizziness / Hypotension / Tachycardia	1/317 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer	1/317 (0.3%)
Reproductive system and breast disorders
Vaginal haemorrhage	1/317 (0.3%)
Uterine Leiomyoma	1/317 (0.3%)
Other (Not Including Serious) Adverse Events
	Esomeprazole 40mg, Daily
	Affected / at Risk (%)	# Events
Total	16/317 (5%)
Nervous system disorders
Headache	16/317 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.