NEXT1: Efficacy of Esomeprazole in Patients With Frequent Heartburn

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01370525
• Collaborator: (none)
• Enrollment: 340
• Locations: 10
• Arms: 2
• Duration (Months): 2
• Patients Per Site: 34
• Patients Per Site Per Month: 17

Study Details

Study Description

Brief Summary

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Condition or Disease	Intervention/Treatment	Phase
Heartburn	Drug: Esomeprazole	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esomeprazole 20 mg	Drug: Esomeprazole; Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Placebo Comparator: Placebo	Drug: Esomeprazole; Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Outcome Measures

Primary Outcome Measures

1. Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [From randomisation to day 14]

2. Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [From randomization to day 14]

Secondary Outcome Measures

1. Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period [From randomisation to day 14]

   Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.

2. Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo [From randomisation to the day 14]

   The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.

3. Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment [From randomisation to day 14]

   There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Males and non-pregnant ,non-lactating females 18 years or older

• Experience heartburn at least 2 days a week

• Having heartburn that has responded to heartburn medication

• Must discontinue any current heartburn medications

Exclusion Criteria:

• Having a history of erosive esophagitis verified by endoscopy

• Having a history of GERD which was diagnosed by a physician

• Inability to take study medication or complete the study and all study procedures

• Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research site	Sacramento	California	United States
2	Research site	Seminole	Florida	United States
3	Research site	Meridian	Idaho	United States
4	Research site	Indianapolis	Indiana	United States
5	Research site	Metairie	Louisiana	United States
6	Research site	Omaha	Nebraska	United States
7	Research site	Raleigh	North Carolina	United States
8	Research site	Cleveland	Ohio	United States
9	Research site	Mt Pleasant	South Carolina	United States
10	Research site	San Antonio	Texas	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Tore Lind, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01370525
• Other Study ID Numbers: D961RC00001
• First Posted: Jun 10, 2011
• Last Update Posted: Mar 14, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by AstraZeneca: Heartburn
• Additional relevant MeSH terms: Heartburn; Esomeprazole

Study Results

Participant Flow

Recruitment Details	From total of 486 enrolled subjects, 340 subjects were randomised. From 340 subjects 171 and 169 were allocated to Esomeprazole and Placebo respectively.

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate	Placebo for Esomeprazole
Period Title: Overall Study
STARTED	171	169
Patients Who Received Treatment	168	163
Patients Who Completed Treatment	163	158
COMPLETED	163	158
NOT COMPLETED	8	11

Baseline Characteristics

Arm/Group Title	Esomeprazole	Placebo	Total
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole	Total of all reporting groups
Overall Participants	171	169	340
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.6 (12.2)	45.9 (12.6)	44.75 (12.4)
Sex: Female, Male (Count of Participants)
Female	105 61.4%	97 57.4%	202 59.4%
Male	66 38.6%	72 42.6%	138 40.6%
Race/Ethnicity, Customized (Number) [Number]
WHITE	103 60.2%	112 66.3%	215 63.2%
BLACK OR AFRICAN AMERICAN	65 38%	55 32.5%	120 35.3%
ASIAN	0 0%	1 0.6%	1 0.3%
AMERICAN INDIAN/ALASKA NATIVE	1 0.6%	0 0%	1 0.3%
OTHER	2 1.2%	1 0.6%	3 0.9%
Race/Ethnicity, Customized (Number) [Number]
HISPANIC OR LATINO	34 19.9%	26 15.4%	60 17.6%
NOT HISPANIC OR LATINO	56 32.7%	59 34.9%	115 33.8%
NOT REPORTED	81 47.4%	84 49.7%	165 48.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time Frame	From randomisation to day 14

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	168	163
Mean (Standard Deviation) [Percentage]	43.32 (34.36)	29.44 (29.83)

2. Secondary Outcome

Title	Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Description	Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
Time Frame	From randomisation to day 14

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	168	163
Number [Participants]	27 15.8%	7 4.1%

3. Secondary Outcome

Title	Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo
Description	The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Time Frame	From randomisation to the day 14

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	168	163
Zero days	64 37.4%	76 45%
One day	25 14.6%	36 21.3%
Two days	36 21.1%	18 10.7%
Three days	25 14.6%	21 12.4%
Four days	18 10.5%	12 7.1%

4. Secondary Outcome

Title	Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Description	There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.
Time Frame	From randomisation to day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	168	163
Last 7 consecutive days	43 25.1%	17 10.1%
Second 7 calender days	43 25.1%	16 9.5%
First 7 calendar days	26 15.2%	10 5.9%

5. Primary Outcome

Title	Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time Frame	From randomization to day 14

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	150	149
Mean (Standard Deviation) [Percentage]	44.52 (34.4)	31.25 (30.26)

Adverse Events

Adverse Event Reporting Description	Full analysis set (FAS) population was analyzed.
Arm/Group Title	Esomeprazole		Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg		Placebo for Esomeprazole
All Cause Mortality
	Esomeprazole		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Esomeprazole		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/168 (0%)		0/163 (0%)
Other (Not Including Serious) Adverse Events
	Esomeprazole		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/168 (10.7%)		15/163 (9.2%)
Blood and lymphatic system disorders
Anaemia	2/168 (1.2%)		2/163 (1.2%)
Gastrointestinal disorders
Nausea	5/168 (3%)		3/163 (1.8%)
Diarhhoea	2/168 (1.2%)		4/163 (2.5%)
Constipation	1/168 (0.6%)		2/163 (1.2%)
Infections and infestations
Nasopharyngitis	4/168 (2.4%)		2/163 (1.2%)
Injury, poisoning and procedural complications
Excoriation	2/168 (1.2%)		0/163 (0%)
Nervous system disorders
Headache	4/168 (2.4%)		0/163 (0%)
Dizziness	0/168 (0%)		2/163 (1.2%)
Renal and urinary disorders
Haematuria	1/168 (0.6%)		2/163 (1.2%)

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.