Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00321984
• Collaborator: (none)
• Enrollment: 947
• Locations: 153
• Arms: 3
• Duration (Months): 6
• Patients Per Site: 6.2
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Dexlansoprazole MR; Drug: Dexlansoprazole MR; Drug: Placebo	Phase 3

Detailed Description

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 947 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexlansoprazole MR 30 mg QD	Drug: Dexlansoprazole MR; Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.; Other Names: TAK-390MR Kapidex Dexilant
Experimental: Dexlansoprazole MR 60 mg QD	Drug: Dexlansoprazole MR; Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.; Other Names: TAK-390MR Kapidex Dexilant
Placebo Comparator: Placebo	Drug: Placebo; Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [4 weeks]

   The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.

2. Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean [4 weeks]

   The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.

Secondary Outcome Measures

1. Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [4 weeks]

   The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.

2. Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean [4 weeks]

   The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).

• Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.

• Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Exclusion Criteria:

• Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.

• Subjects with erosive esophagitis (EE) as shown by endoscopy.

• Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.

• Subject has abnormal laboratory values.

• Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.

• Subject known to have acquired immunodeficiency syndrome (AIDS).

• Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.

• Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.

• Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.

• Use of antacids (except for study-supplied Gelusil® ).

• Use of drugs with significant anticholinergic effects.

• Subjects who cannot discontinue the use of misoprostol or prokinetics

• Need for continuous anticoagulant therapy.

• Females who are pregnant or lactating.

• History of gastrointestinal surgery except for simple oversew of ulcer.

• History of cancer within 3 years prior to screening.

• Subject has participated in a previous Dexlansoprazole study.

• Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Alabaster	Alabama	United States
2		Birmingham	Alabama	United States
3		Hueytown	Alabama	United States
4		Huntsville	Alabama	United States
5		Northport	Alabama	United States
6		Tallassee	Alabama	United States
7		Chandler	Arizona	United States
8		North Little Rock	Arizona	United States
9		Sun City	Arizona	United States
10		Tempe	Arizona	United States
11		Tucson	Arizona	United States
12		Anaheim	California	United States
13		Azusa	California	United States
14		Carmichael	California	United States
15		Chula Vista	California	United States
16		Clearwater	California	United States
17		Cypress	California	United States
18		Fountain Valley	California	United States
19		Fullerton	California	United States
20		Garden Grove	California	United States
21		Irvine	California	United States
22		Lancaster	California	United States
23		Mission Hills	California	United States
24		Oakland	California	United States
25		Orange	California	United States
26		Palm Springs	California	United States
27		Pasadena	California	United States
28		Redwood City	California	United States
29		San Diego	California	United States
30		San Francisco	California	United States
31		San Luis Obispo	California	United States
32		Vista	California	United States
33		Westlake Village	California	United States
34		Boulder	Colorado	United States
35		Colorado Springs	Colorado	United States
36		Littleton	Colorado	United States
37		Lone Tree	Colorado	United States
38		Wheat Ridge	Colorado	United States
39		Bristol	Connecticut	United States
40		Waterbury	Connecticut	United States
41		Boynton Beach	Florida	United States
42		Clearwater	Florida	United States
43		Holly Hill	Florida	United States
44		Jupitor	Florida	United States
45		Kissimmee	Florida	United States
46		Miami	Florida	United States
47		Naples	Florida	United States
48		New Smyma Beach	Florida	United States
49		Ocala	Florida	United States
50		Pembroke Pines	Florida	United States
51		Saint Petersburg	Florida	United States
52		West Palm Beach	Florida	United States
53		Zephyrhills	Florida	United States
54		Atlanta	Georgia	United States
55		Conyers	Georgia	United States
56		Dunwoody	Georgia	United States
57		Stockbridge	Georgia	United States
58		Honolulu	Hawaii	United States
59		Boise	Idaho	United States
60		Moline	Illinois	United States
61		Oak Forrest	Illinois	United States
62		Rockford	Illinois	United States
63		Indianapolis	Indiana	United States
64		Clive	Iowa	United States
65		Dubuque	Iowa	United States
66		Overland	Kansas	United States
67		Wichita	Kansas	United States
68		Lexington	Kentucky	United States
69		Louisville	Kentucky	United States
70		Baton Rouge	Louisiana	United States
71		Metairie	Louisiana	United States
72		Baltimore	Maryland	United States
73		Chevy Chase	Maryland	United States
74		Hollywood	Maryland	United States
75		Lutherville	Maryland	United States
76		Prince Frederick	Maryland	United States
77		Troy	Michigan	United States
78		Chaska	Minnesota	United States
79		Jackson	Mississippi	United States
80		Olive Branch	Mississippi	United States
81		Jefferson City	Missouri	United States
82		Mexico	Missouri	United States
83		Washington	Missouri	United States
84		Butte	Montana	United States
85		Las Vegas	Nevada	United States
86		Pahrump	Nevada	United States
87		Egg Harbor Town	New Jersey	United States
88		Albuquerque	New Mexico	United States
89		Binghamton	New York	United States
90		Great Neck	New York	United States
91		Rochester	New York	United States
92		Charlotte	North Carolina	United States
93		Greensboro	North Carolina	United States
94		Harrisburg	North Carolina	United States
95		High Point	North Carolina	United States
96		Raleigh	North Carolina	United States
97		Statesville	North Carolina	United States
98		Bismark	North Dakota	United States
99		Cincinnati	Ohio	United States
100		Cleveland	Ohio	United States
101		Columbus	Ohio	United States
102		Dayton	Ohio	United States
103		Franklin	Ohio	United States
104		Kettering	Ohio	United States
105		Lyndhurst	Ohio	United States
106		Mogadore	Ohio	United States
107		Sylvania	Ohio	United States
108		Oklahoma City	Oklahoma	United States
109		Medford	Oregon	United States
110		Portland	Oregon	United States
111		Duncansville	Pennsylvania	United States
112		Harleysville	Pennsylvania	United States
113		Lansdale	Pennsylvania	United States
114		Levittown	Pennsylvania	United States
115		Anderson	South Carolina	United States
116		Charleston	South Carolina	United States
117		Mount Pleasant	South Carolina	United States
118		Varnville	South Carolina	United States
119		Sioux Falls	South Dakota	United States
120		Bristol	Tennessee	United States
121		Chattanooga	Tennessee	United States
122		Germantown	Tennessee	United States
123		Hermitage	Tennessee	United States
124		Jackson	Tennessee	United States
125		Johnson City	Tennessee	United States
126		Kingsport	Tennessee	United States
127		Nashville	Tennessee	United States
128		Amarillo	Texas	United States
129		Austin	Texas	United States
130		Beaumont	Texas	United States
131		Bellaire	Texas	United States
132		Bryan	Texas	United States
133		Carollton	Texas	United States
134		Conroe	Texas	United States
135		Corsicana	Texas	United States
136		Dallas	Texas	United States
137		El Paso	Texas	United States
138		Fort Worth	Texas	United States
139		Houston	Texas	United States
140		Lake Jackson	Texas	United States
141		San Antonio	Texas	United States
142		Midvale	Utah	United States
143		Ogden	Utah	United States
144		Salt Lake City	Utah	United States
145		Charlottesville	Virginia	United States
146		Chesapeake	Virginia	United States
147		Norfold	Virginia	United States
148		Richmond	Virginia	United States
149		Lakewood	Washington	United States
150		Spokane	Washington	United States
151		Tacoma	Washington	United States
152		Milwaukee	Wisconsin	United States
153		Monroe	Wisconsin	United States

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• For the Dexilant package insert refer to this link

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00321984
• Other Study ID Numbers: T-GD05-137; 2006-000420-13; U1111-1114-1935
• First Posted: May 4, 2006
• Last Update Posted: Apr 28, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: Gastroesophageal Reflux Disease(GERD); Heartburn
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Dexlansoprazole; Lansoprazole

Study Results

Participant Flow

Recruitment Details	Subjects enrolled at 154 sites in the United States (US); date of first dose: 08 June 2006; date of last procedure: 11 December 2006.
Pre-assignment Detail	Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of gastroesophageal reflux disease (GERD) should not be altered throughout the study.

Arm/Group Title	Placebo QD	Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR 60 mg QD
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Period Title: Overall Study
STARTED	317	315	315
COMPLETED	290	294	289
NOT COMPLETED	27	21	26

Baseline Characteristics

Arm/Group Title	Placebo QD	Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR 60 mg QD	Total
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.	Total of all reporting groups
Overall Participants	317	315	315	947
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (14.40)	47.6 (13.55)	47.5 (13.77)	47.5 (13.90)
Age, Customized (participants) [Number]
<45 years	130 41%	131 41.6%	139 44.1%	400 42.2%
45 to <65 years	148 46.7%	149 47.3%	136 43.2%	433 45.7%
≥65 years	39 12.3%	35 11.1%	40 12.7%	114 12%
Sex: Female, Male (Count of Participants)
Female	233 73.5%	231 73.3%	209 66.3%	673 71.1%
Male	84 26.5%	84 26.7%	106 33.7%	274 28.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.9%	0 0%	2 0.6%	5 0.5%
Asian	5 1.6%	4 1.3%	7 2.2%	16 1.7%
Native Hawaiian or Other Pacific Islander	3 0.9%	1 0.3%	0 0%	4 0.4%
Black or African American	45 14.2%	37 11.7%	48 15.2%	130 13.7%
White	255 80.4%	267 84.8%	251 79.7%	773 81.6%
More than one race	4 1.3%	3 1%	6 1.9%	13 1.4%
Unknown or Not Reported	2 0.6%	3 1%	1 0.3%	6 0.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	62 19.6%	67 21.3%	53 16.8%	182 19.2%
Not Hispanic or Latino	255 80.4%	248 78.7%	262 83.2%	765 80.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Description	The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.

Arm/Group Title	Placebo QD	Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR 60 mg QD
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Measure Participants	310	312	307
Median (Inter-Quartile Range) [percentage of days]	18.5	54.9	50.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD, Dexlansoprazole MR 30 mg QD
	Comments	The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.00001
	Comments	The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD, Dexlansoprazole MR 60 mg QD
	Comments	The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.00001
	Comments	The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dexlansoprazole MR 30 mg QD, Dexlansoprazole MR 60 mg QD
	Comments	The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.72941
	Comments	Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Description	The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.

Arm/Group Title	Placebo QD	Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR 60 mg QD
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Measure Participants	310	312	307
Mean (Standard Deviation) [percentage of days]	25.0 (25.6)	50.3 (33.9)	49.1 (34.7)

3. Secondary Outcome

Title	Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Description	The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.

Arm/Group Title	Placebo QD	Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR 60 mg QD
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Measure Participants	308	311	307
Median (Inter-Quartile Range) [percentage of days]	51.7	80.8	76.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD, Dexlansoprazole MR 30 mg QD
	Comments	The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.00001
	Comments	The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD, Dexlansoprazole MR 60 mg QD
	Comments	The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.00001
	Comments	The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dexlansoprazole MR 30 mg QD, Dexlansoprazole MR 60 mg QD
	Comments	The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31460
	Comments	Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Description	The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.

Arm/Group Title	Placebo QD	Dexlansoprazole MR 30 mg QD	Dexlansoprazole MR 60 mg QD
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Measure Participants	308	311	307
Mean (Standard Deviation) [percentage of days]	47.1 (32.6)	67.6 (34.1)	65.0 (34.3)

Adverse Events

Arm/Group Title	Placebo QD		Dexlansoprazole MR 30 mg QD		Dexlansoprazole MR 60 mg QD
Arm/Group Description	Placebo capsules, orally, once daily for up to 4 weeks.		Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.		Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
All Cause Mortality
	Placebo QD		Dexlansoprazole MR 30 mg QD		Dexlansoprazole MR 60 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo QD		Dexlansoprazole MR 30 mg QD		Dexlansoprazole MR 60 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/ (NaN)		2/ (NaN)		1/ (NaN)
Cardiac disorders
Coronary Artery Disorders Not Elsewhere Classified (NEC)	1/317 (0.3%)		0/315 (0%)		0/315 (0%)
Ischaemic Coronary Artery Disorders	0/317 (0%)		2/315 (0.6%)		0/315 (0%)
Heart Failures NEC	0/317 (0%)		1/315 (0.3%)		0/315 (0%)
Gastrointestinal disorders
Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)	0/317 (0%)		0/315 (0%)		1/315 (0.3%)
Non-site Specific Gastrointestinal Haemorrhages	0/317 (0%)		0/315 (0%)		1/315 (0.3%)
Infections and infestations
Sepsis, Bacteraemia, Viraemia and Fungaemia NEC	0/317 (0%)		1/315 (0.3%)		0/315 (0%)
Nervous system disorders
Central Nervous System Haemorrhage & Cerebrovascular Accidents	0/317 (0%)		1/315 (0.3%)		0/315 (0%)
Other (Not Including Serious) Adverse Events
	Placebo QD		Dexlansoprazole MR 30 mg QD		Dexlansoprazole MR 60 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/ (NaN)		41/ (NaN)		36/ (NaN)
Gastrointestinal disorders
Diarrhoea (Excluding Infective)	11/317 (3.5%)		18/315 (5.7%)		15/315 (4.8%)
Nausea and Vomiting Symptoms	9/317 (2.8%)		16/315 (5.1%)		18/315 (5.7%)
Nervous system disorders
Headaches NEC	19/317 (6%)		13/315 (4.1%)		9/315 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.