NEXT2: Efficacy of Esomeprazole in Patients With Frequent Heartburn

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01370538
• Collaborator: (none)
• Enrollment: 341
• Locations: 10
• Arms: 2
• Duration (Months): 2
• Patients Per Site: 34.1
• 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: 341 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]

Secondary Outcome Measures

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

   Treatment period is considered to be 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 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	Mobile	Alabama	United States
2	Research site	San Francisco	California	United States
3	Research site	Westlake Village	California	United States
4	Research site	Lexington	Kentucky	United States
5	Research site	Rochester	New York	United States
6	Research site	Dakota Dunes	South Dakota	United States
7	Research site	Nashville	Tennessee	United States
8	Research site	Austin	Texas	United States
9	Research site	San Angelo	Texas	United States
10	Research site	West Jordan	Utah	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: NCT01370538
• Other Study ID Numbers: D961RC00002
• First Posted: Jun 10, 2011
• Last Update Posted: Apr 11, 2013
• Last Verified: Mar 1, 2013

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

Study Results

Participant Flow

Recruitment Details	From total of 526 screened subjects, 341 subjects were randomised. From 341 subjects 170 and 171 were allocated to Esomeprazole and Placebo respectively.

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Period Title: Overall Study
STARTED	170	171
Patients Who Received Treatment	165	161
Patients Who Completed Treatment	151	152
COMPLETED	151	152
NOT COMPLETED	19	19

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	170	171	341
Age (Years) [Mean (Standard Deviation) ]
All	41.6 (14.0)	42.8 (13.2)	42.2 (13.6)
Sex: Female, Male (Count of Participants)
Female	91 53.5%	87 50.9%	178 52.2%
Male	79 46.5%	84 49.1%	163 47.8%
Race/Ethnicity, Customized (Number) [Number]
WHITE	111 65.3%	120 70.2%	231 67.7%
BLACK OR AFRICAN AMERICAN	52 30.6%	50 29.2%	102 29.9%
NATIVE HAWAIIAN/PACIFIC ISLANDER	1 0.6%	0 0%	1 0.3%
AMERICAN INDIAN/ALASKA NATIVE	3 1.8%	0 0%	3 0.9%
OTHER	3 1.8%	1 0.6%	4 1.2%
Race/Ethnicity, Customized (Number) [Number]
HISPANIC OR LATINO	24 14.1%	25 14.6%	49 14.4%
NOT HISPANIC OR LATINO	55 32.4%	46 26.9%	101 29.6%
NOT REPORTED	91 53.5%	100 58.5%	191 56%

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	162	158
Mean (Standard Deviation) [Percentage of heartburn free days]	46.79 (33.32)	30.93 (28.86)

2. Secondary Outcome

Title	Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Description	Treatment period is considered to be both weeks 1 and 2 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	162	158
Number [Participants]	27 15.9%	2 1.2%

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 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	162	158
Zero days	55 32.4%	77 45%
One day	32 18.8%	34 19.9%
Two days	22 12.9%	29 17%
Three days	37 21.8%	16 9.4%
Four days	16 9.4%	2 1.2%

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

Full Analysis Set

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	162	158
Last 7 consecutive days	40 23.5%	17 9.9%
Second 7 calendar days	38 22.4%	13 7.6%
First 7 calendar days	32 18.8%	7 4.1%

5. 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

Per-protocol analysis set

Arm/Group Title	Esomeprazole	Placebo
Arm/Group Description	Esomeprazole magnesium trihydrate 22.3 mg	Placebo for Esomeprazole
Measure Participants	142	140
Mean (Standard Deviation) [Percentage of heartburn free days]	47.82 (33.23)	28.83 (31.22)

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	0/162 (0%)		0/158 (0%)
Other (Not Including Serious) Adverse Events
	Esomeprazole		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/162 (11.1%)		15/158 (9.5%)
Gastrointestinal disorders
Nausea	5/162 (3.1%)		4/158 (2.5%)
Constipation	4/162 (2.5%)		0/158 (0%)
Diarrhoea	4/162 (2.5%)		3/158 (1.9%)
Dry mouth	1/162 (0.6%)		2/158 (1.3%)
Vomiting	0/162 (0%)		2/158 (1.3%)
General disorders
Pain	0/162 (0%)		3/158 (1.9%)
Pyrexia	0/162 (0%)		2/158 (1.3%)
Infections and infestations
Nasopharyngitis	2/162 (1.2%)		2/158 (1.3%)
Upper respiratory tract infection	2/162 (1.2%)		2/158 (1.3%)
Urinary tract infection	2/162 (1.2%)		1/158 (0.6%)
Injury, poisoning and procedural complications
Procedural pain	1/162 (0.6%)		2/158 (1.3%)
Investigations
Blood glucose decreased	2/162 (1.2%)		1/158 (0.6%)
Blood glucose increased	1/162 (0.6%)		2/158 (1.3%)
Haemoglobin decreased	2/162 (1.2%)		1/158 (0.6%)
Hepatic enzyme increased	0/162 (0%)		2/158 (1.3%)
Musculoskeletal and connective tissue disorders
Myalgia	3/162 (1.9%)		0/158 (0%)
Nervous system disorders
Headache	2/162 (1.2%)		2/158 (1.3%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	3/162 (1.9%)		1/158 (0.6%)

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.