Efficacy and Safety of Dexlansoprazole MR and Lansoprazol... | NCT00251693

ID	Type	Description	Link
U1111-1113-9373	Registry Identifier	WHO

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

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 (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.	Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. 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 was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. 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 erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. 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.

Eligibility Module

Name	Affiliation	Role
Medical Director	Takeda	Study Chair

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

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
	BG000269 BG001276 BG002288 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00047.8± 13.71 BG00147.3± 13.93 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000300 BG001302 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00060 BG00152 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0006 BG0014 BG002

Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)

LA Classification for Esophagitis Grading System (grades A, B, C, D) with increasing severity from grade A to grade D.

Number

Paricipants

Title

Denominators

Categories

A: ≥1 mucosal break <5mm

Title	Measurements
	BG000236 BG001242

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 (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. 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 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

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	OG000639 OG001634 OG002656

Title

Denominators

Categories

Title	Measurements
	OG00085.3(82.3 to 87.9) OG00185.8(82.8 to 88.4) OG00279.0(75.6 to 82.0)

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		0.004	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	6.33				95	2.17	10.48				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 erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. 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

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 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 for Change in LA Esophagitis Classification Grades C and D to healed. 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 was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. 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 Analyses.

Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. 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 was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. 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.	5	680	63	680
EG001	Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.	2	668	53	668
EG002	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.	6	690	50	690

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary Artery Disorders not elsewhere classified (NEC)	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Duodenal and Small Intestinal Stenosis and Obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Gastrointestinal (GI) Atonic and Hypomotility Disorders NEC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Gastrointestinal Inflammatory Disorders NEC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0011 affected668 at risk EG0020 affected690 at risk
Haemorrhoids and GI Varices (Excluding [Excl] Oesophageal)	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0011 affected668 at risk EG0020 affected690 at risk
Intestinal Ulcers and Perforation NEC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Peritoneal and Retroperitoneal Disorders	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Pain and Discomfort NEC	General disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Cholecystitis and Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Infections NEC	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Lower Respiratory Tract and Lung Infections	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Sepsis, Bacteraemia, Viraemia and Fungaemia NEC	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Streptococcal Infections	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Non-site Specfic Procedural Complications	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Potassium Imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Soft Tissue Disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Acute Polyneuropathies	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Transient Cerebrovascular (CV) Events	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk
Paralysis and Paresis (Excl Cranial Nerve)	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Central Nervous System Hemorrhages and CV accidents	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Bipolar Disorders	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected680 at risk EG0010 affected668 at risk EG0021 affected690 at risk
Respiratory Failures (Excl Neonatal)	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected680 at risk EG0010 affected668 at risk EG0020 affected690 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea (Excl Infective)	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00027 affected680 at risk EG00124 affected668 at risk EG00221 affected690 at risk
Gastrointestinal and Abdominal Pains (Excl Oral and Throat)	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 affected680 at risk EG00124 affected668 at risk EG00217 affected690 at risk
Upper Respiratory Tract Infections	Infections and infestations	MedDRA	Systematic Assessment	EG00024 affected680 at risk EG00117 affected668 at risk EG00217 affected690 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Alabaster	Alabama		United States

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

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