Efficacy and Safety of Dexlansoprazole MR and Lansoprazol... | NCT00251719

ID	Type	Description	Link
U1111-1114-0058	Registry Identifier	WHO

Efficacy and Safety of Dexlansoprazole MR and Lansoprazol... | NCT00251719 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Dexlansoprazole MR 60 mg QD	Experimental	Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg QD	Experimental	Drug: Dexlansoprazole MR
Lansoprazole 30 mg QD	Active Comparator	Drug: Lansoprazole

Name	Type	Description	Arm Group Labels	Other Names
Dexlansoprazole MR	Drug	Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.	Dexlansoprazole MR 60 mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.	Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.	8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method	Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.	8 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.	Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Takeda	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19183157	Result	Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x.
19735233

Label	URL
For the Dexilant Package Insert refer to this link	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
FG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG00014 subjects FG0018 subjects FG0027 subjects
Protocol Violation		FG0001 subjects FG0011 subjects FG0021 subjects
Lost to Follow-up		FG0005 subjects FG00111 subjects FG0028 subjects
Withdrawal by Subject		FG00014 subjects FG00112 subjects FG00211 subjects
Lack of Efficacy		FG0002 subjects FG0011 subjects FG0020 subjects
Inclusion/exclusion criteria not met		FG00012 subjects FG0016 subjects FG0022 subjects
Investigator decision		FG0001 subjects FG0011 subjects FG0020 subjects
Noncompliance		FG0002 subjects FG0013 subjects FG0021 subjects
Barrett's esophagus		FG0002 subjects FG0012 subjects FG0020 subjects

Arm/Group Information

ID	Title	Description
BG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
BG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
BG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

< 45 Years

Title	Measurements
	BG000255 BG001293 BG002294 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00048.7± 13.53 BG00147.7± 13.80 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000317 BG001335 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00067 BG00167 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0006 BG00112 BG002

LA Classification Grade

Number

participant

Title

Denominators

Categories

A: ≥1 mucosal break <5 mm

Title	Measurements
	BG000234 BG001271 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.

Crude rate analysis were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment that was performed within 7 days of the last day of study drug.

Posted

Number

percentage of subjects

8 Weeks

ID	Title	Description
OG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
OG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
OG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Units	Counts
Participants	OG000657 OG001652 OG002648

Title

Denominators

Categories

Title	Measurements
	OG00086.9 OG00189.4 OG00284.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Cochran-Mantel-Haenszel		0.234	Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.	Difference in percentage	2.34				95	-1.45	6.14				Yes	Non-Inferiority or Equivalence	If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.

Secondary

Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.

Posted

Number

percentage of subjects

Week 8

ID	Title	Description
OG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
OG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
OG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Secondary

Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.

Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.

Posted

Number

percentage of subjects

8 Weeks

ID	Title	Description
OG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
OG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
OG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Primary

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

Posted

Number

percentage of subjects

8 Weeks

ID	Title	Description
OG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
OG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
OG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Secondary

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.

Posted

Number

percentage of subjects

4 Weeks

ID	Title	Description
OG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
OG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
OG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Secondary

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.

Posted

Number

percentage of subjects

4 Weeks

ID	Title	Description
OG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
OG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
OG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.	4	694	30	694
EG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.	4	687	31	687
EG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.	2	673	23	673

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ischaemic Coronary Artery Disorders	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected694 at risk EG0011 affected687 at risk EG0020 affected673 at risk
Pain and Discomfort not elsewhere classified (NEC)	General disorders	MedDRA	Systematic Assessment	EG0001 affected694 at risk EG0010 affected687 at risk EG0020 affected673 at risk
Cholecystitis and Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected694 at risk EG0011 affected687 at risk EG0021 affected673 at risk
Abdominal and Gastrointestinal Infections	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected694 at risk EG0011 affected687 at risk EG0020 affected673 at risk
Non-site Specific Injuries NEC	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected694 at risk EG0010 affected687 at risk EG0020 affected673 at risk
Site Specific Injuries NEC	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected694 at risk EG0010 affected687 at risk EG0020 affected673 at risk
Breast and Nipple Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected694 at risk EG0010 affected687 at risk EG0020 affected673 at risk
Facial Cranial Nerve Disorders	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected694 at risk EG0010 affected687 at risk EG0021 affected673 at risk
Renal Lithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected694 at risk EG0011 affected687 at risk EG0020 affected673 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diarrhoea (Excluding Infective)	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG00030 affected694 at risk EG00131 affected687 at risk EG00223 affected673 at risk

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D005759	Gastroenteritis
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D013272	Stomach Diseases

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Group IDs	Statistical Method	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Cochran-Mantel-Haenszel	0.768	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG001 OG002	Cochran-Mantel-Haenszel	0.064	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.034	Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.	95	No	Superiority or Other

Group IDs	Statistical Method	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Log Rank	0.727	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG001 OG002	Log Rank	0.064	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG000 OG001	Log Rank	0.174	Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.	95	No	Superiority or Other

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG002	Log Rank	0.167	Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.	Difference in percentage	1.65	95	-1.65	4.96	Yes	Non-Inferiority or Equivalence	Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.
OG001 OG002	Log Rank	0.030	Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.	Difference in percentage	3.39	95	0.27	6.50	Yes	Non-Inferiority or Equivalence	Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.
OG000 OG001	Log Rank	0.413	Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.			95			No	Superiority or Other

Group IDs	Statistical Method	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Cochran-Mantel-Haenszel	0.100	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG001 OG002	Cochran-Mantel-Haenszel	0.125	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.993	Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.	95	No	Superiority or Other

Group IDs	Statistical Method	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Log Rank	0.117	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG001 OG002	Log Rank	0.124	Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.	95	No	Superiority or Other
OG000 OG001	Log Rank	0.949	Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.	95	No	Superiority or Other

Facility	Status	City	State	ZIP	Country	Contacts
		Anniston	Alabama		United States